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Kshirsagar, Sanjay
- Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin HCl and Gliclazide
Abstract Views :278 |
PDF Views:6
Authors
Affiliations
1 Department of Pharmaceutical Analysis, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, IN
1 Department of Pharmaceutical Analysis, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 6, No 3 (2016), Pagination: 151-154Abstract
A new, simple and validated RP-HPLC method was developed for simultaneous estimation of MetforminHCl (MET) and Gliclazide (GLZ).The separation was achieved by using mobile phase Methanol: 10 mM Phosphate buffer (pH 3) 70:30 % v/v on Kinetics C18 column (250 x 4.6 mm, 5μ). The flow rate was 1 ml/min. The detection was carried out at wavelength 230 nm.The retention time of MET and GLZ was found to be 2.20 min and 4.67 min, respectively. Calibration curves for MET and GLZ were found to be linear in the range of 10-60 μg/ml and 2-12 μg/ml, respectively. The proposed method was validated as per ICH guideline Q2 (R1). The validation parameters studied were linearity, accuracy, precision, specificity and robustness. All validation parameters were found within the acceptable range.Keywords
Metformin HCl, Gliclazide, RP-HPLC, Analytical Method Validation.
- Development of a Validated RP-HPLC Method for Estimation of Ethionamide in Spiked Human Plasma with UV Detection
Abstract Views :262 |
PDF Views:1
Authors
Affiliations
1 Department of Pharmaceutical Analysis, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, IN
1 Department of Pharmaceutical Analysis, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, IN
Source
Asian Journal of Research in Pharmaceutical Sciences, Vol 6, No 4 (2016), Pagination: 230-234Abstract
A simple, rapid and economic RP-HPLC method was developed and validated for estimation of Ethionamide in spiked human plasma. The drug along with Guaifenesin (used as internal standard) was extracted from plasma by liquid-liquid extraction (LLE) procedure using ethyl acetate as organic solvent. The drug was well resolved from the plasma interference and internal standard in a reversed phase mode on C 18 (250 × 4.6 mm, 5 μ) column with methanol: water (40: 60 %, v/v) as mobile phase, at a flow rate of 1 mL/min. The detection was performed at 275 nm. The developed method was validated as per the US-FDA guidelines, where the weighted linear regression was used in calibration experiments to obtain the homoscedasticity. In accuracy and precision studies, intra-day and inter-day, % relative error was found between ± 15 and % RSD was less than 15 %. Stability experiments indicated that the drug remained stable after three freeze-thaw cycles.Keywords
Ethionamide, Bioanalytical, Liquid-Liquid Extraction, Weighted Regression, RP-HPLC.- Development and Validation of Simple UV- Spectrophotometric Method for the Determination of Empagliflozin
Abstract Views :277 |
PDF Views:1
Authors
Sushil D. Patil
1,
Sayali K. Chaure
1,
Maswood Ahmed Hafizur Rahman
1,
Prajkta U. Varpe
1,
Sanjay Kshirsagar
1
Affiliations
1 MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra State 422003, IN
1 MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra State 422003, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 1 (2017), Pagination: 18-22Abstract
A rapid, specific and economic UV Spectrophotometric method has been developed using a solvent composed of water: methanol (9.0:1.0) to determine the empagliflozin content in bulk. At a pre-determined λmax of 224 nm, it was proved linear in the range of 1.0-3.0 μg/mL, and exhibited good correlation coefficient (R2=0.998) and minimum sum of square error 0.0595, Hence we have selected equation of line of 50-90% (best fit line) linearity throughout experiment. The method was validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. The obtained results proved that the method can be employed for the routine analysis of empagliflozin in bulks as well as in the commercial formulations.Keywords
UV, Empagliflozin, Method Development and Validation, ICH Guideline.- Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Empagliflozin and Metformin Hydrochloride in Bulk Drugs
Abstract Views :453 |
PDF Views:11
Authors
Affiliations
1 MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, MS 422003, IN
1 MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, MS 422003, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 2 (2017), Pagination: 117-123Abstract
A new, simple, accurate and sensitive UV-spectrophotometric absorption correction method has been developed for simultaneous determination of Metformin HCl and Empagliflozin in bulk utilizing concept of standard addition. The method is based upon determination of Empagliflozin at 224 nm & Metformin HCl at 230 nm methanol as a solvent. Overlay spectra of both drugs shows absorbance at 227 nm. Linearity was observed in range of 10-50 μg/ml and 1-3 μg/ml for Metformin HCl and Empagliflozin respectively. The correlation coefficient value was found to near to 1.All methods were statistically validated as per ICH guidelines.Keywords
Metformin HCl, Empagliflozin, UV-Spectrophotometric, Simultaneous Estimation, Method Development and Validation, ICH Guideline.- Development of RP-HPLC Method for Separation of Atorvastatin Calcium, Amlodipine Besylate and Azilsartan Medoxomil and its Application to Analyze their Tablet Dosage Forms
Abstract Views :328 |
PDF Views:6
Authors
Affiliations
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, IN
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, IN
Source
Asian Journal of Pharmaceutical Research, Vol 7, No 3 (2017), Pagination: 148-154Abstract
A single, simple, accurate and precise RP-HPLC method has been developed for the separation amlodipine besylate in presence of azilsartan medoxomil and atorvastatin calciumand estimation in their respective combined dosage forms. The chromatographic separation was achieved on C18 column (250×4.6 mm, 5 μ) using Acetonitrile: 20 mM Phosphate buffer (pH 3) 60:40 v/v as a mobile phase at flow rate of 0.8 mL/min. The separation was achieved in isocratic mode and the detection was performed at 242 nm. Further the developed method was validated as per the ICH Q2 (R1) and applied for quantitation of atorvastatin calcium-amlodipine besylate and amlodipine besylate-azilsartan medoxomil in tablet formulations.Keywords
Amlodipine Besylate, Azilsartan Medoxomil, Atorvastatin Calcium, RP-HPLC, Analytical Method Validation.- Development and Validation of RP-HPLC Method for Simultaneous Estimation of Telmisartan, Amlodipine Besylate and Hydrochlorthiazide in their Tablet Dosage Form
Abstract Views :300 |
PDF Views:0
Authors
Affiliations
1 MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, IN
1 MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 422 003, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 3 (2017), Pagination: 189-195Abstract
To treat the second stage high blood pressure, physicians prefers the combination drug therapy consisting of two or more anti-hypertensive agents. Among these, telmisartan with amlodipine besylate, telmisartan with hydrochlorthiazide as well as triple drug therapy consisting of amlodipine besylate, telmisartan and hydrochlorthiazide are commonly prescribed. In the present paper, a simple, accurate and precise RP-HPLC method was developed for the estimation of amlodipine besylate, telmisartan and hydrochlorthiazide in bulk and combined dosage form. All these three drugs were successfully separated and resolved from each other on C18 kinetex column (250 × 4.6 mm, 5 μ), using acetonitrile: 20mM phosphate buffer (pH 3.0) (60:40 %, v/v) as a mobile phase at a flow rate of 1 mL/min. The detection was performed at 258 nm. The developed method was further validated as per ICH Q2 (R1) guidelines.Keywords
Telmisartan, Amlodipine Besylate, Hydrochlorthiazide, RP-HPLC, Analytical Method Validation.References
- Wan, X., P. Ma, and X. Zhang, A promising choice in hypertension treatment: Fixed-dose combinations. Asian Journal of Pharmaceutical Sciences, 2014,9(1): p. 1-7.
- Kondawar, M., et al., UV spectrophotometric estimation of amlodipine besylate and telmisartan in bulk drug and dosage form by multiwavelength analysis. Int. J Chem Tech Res, 2011. 3: p.1274-8.
- Kranthi, M. and A. Srinivas, Analytical Method Development and Validation and Force Degradation Studies for Simultaneous Estimation of Amlodipine Besylate and Telmisartan in Tablet Dosage Form by using RP-HPLC. International Journal of Pharmaceutical and Phytopharmacological Research, 2017,4(1): p.2-7.
- Thomas, A.B., et al., Simultaneous spectrophotometric estimation of amlodipine besylate and telmisartan in tablet dosage form. Int J Pharm Tech Res, 2010, 2: p. 1334-1341.
- Vekariya, N., et al., Application of TLC-densitometry method for simultaneous estimation of telmisartan and amlodipine besylate in pharmaceutical dosage form. Int. J. Pharm. Res, 2009, 1(4): p.1644-1649.
- Shah, N., et al., Development and validation of a HPTLC method for the simultaneous estimation of telmisartan and hydrochlorothiazide in tablet dosage form. Indian Journal of Pharmaceutical Sciences, 2007,69(2): p. 202.
- Wankhede, S.B., et al., RP-HPLC method for simultaneous estimation of telmisartan and hydrochlorothiazide in tablet dosage form. Indian journal of pharmaceutical sciences, 2007, 69(2): p.298.
- Gangola, R., S. Kaushik, and P. Sharma, Spectrophotometric simultaneous determination of hydrochlorothiazide and telmisartan in combined dosage form. Journal of Applied Pharmaceutical Science, 2011, 1(1): p. 46.
- Kavitha, J., et al., Development and validation of RP-HPLC method for simultaneous estimation of telmisartan and hydrochlorothiazide in tablets: its application to routine quality control analysis. Int J Pharm Pharm Sci, 2011, 3: p. 113-5.
- Rane, V., J. Sangshetti, and D. Shinde, Simultaneous highperformance liquid chromatographic determination of telmisartan and hydrochlorothiazide in pharmaceutical preparation. Journal of Chromatographic Science, 2008. 46(10): p. 887-891.
- Bhatia, N., et al., Development and validation of spectrophotometric and ion pair chromatographic techniques for estimation of telmisartan and hydrochlorothiazide. 2010.
- Maheswari, R., et al., Simultaneous estimation of telmisartan and hydrochlorothiazide in tablet dosage form by HPTLC method.Asian Journal of Chemistry, 2007, 19(7): p. 5582.
- Nalwade, S., et al., Rapid simultaneous determination of telmisartan, amlodipine besylate and hydrochlorothiazide in a combined poly pill dosage form by stability-indicating ultraperformance liquid chromatography. Scientia Pharmaceutica, 2011, 79(1): p. 69-84.
- Sinojiya, R.S., et al., Development and Validation of RP-HPLC Method for the Simultaneous Determination of Telmisartan, Amlodipine Besylate and Hydrochlorothiazide in a Tablet Dosage Form. Journal of Pharmacy Research Vol, 2012,5(8): p. 41544157.
- Mhaske, R., et al., RP-HPLC method for simultaneous determination of amlodipine Besylate, Valsartan, Telmisartan, Hydrochlorothiazide and Chlorthalidone: application to commercially available drug products. International Journal of Pharmaceutical Sciences and Research, 2012,3(1): p. 141.
- Validation of Analytical Procedures: Text and Methodology, Q2R1, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonized Triplicate Guidelines 2005.
- Development of a RP-HPLC Method for Separation of Ezetimibe in Presence of Atorvastatin Caclium and Simvastatin and its Application for Qunatitation of Tablet Dosage Forms
Abstract Views :261 |
PDF Views:0
Authors
Affiliations
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, IN
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 3 (2017), Pagination: 169-175Abstract
A single, simple, accurate and precise RP-HPLC method has been developed for the estimation of ezetimibe in presence of atorvastatin calcium and simvastatin in bulk and marketed combined formulations. The chromatographic separation was achieved on C18 column (250 × 4.6 mm, 5 μ) using Acetonitrile: water 70:30 v/v as a mobile phase at flow rate of 1.2 mL/min. The separation was achieved in isocratic mode and the detection was performed at 242 nm. Further the developed method was validated as per the ICH Q2 (R1) and applied for quantitation of atorvastatin calcium-ezetimibe and ezetimibe – simvastatin in tablet formulations.Keywords
Ezetimibe, Simvastatin, Atorvastatin Calcium, RP-HPLC, Analytical Method Validation.References
- www.panacea-biotec.com/product-pdf/Lower.pdf.
- Inazawa, T., et al., Research (Recognized effect of Statin and ezetimibe therapy for achieving LDL-C Goal), a randomized, doctor-oriented, multicenter trial to compare the effects of higherdose statin versus ezetimibe-plus-statin on the serum LDL-C concentration of Japanese type-2 diabetes patients design and rationale. Lipids in Health and Disease, 2013. 12(1): p. 142.
- Qutab, S.S., S.N. Razzaq, and I.U. Khan, Simultaneous determination of atorvastatin calcium and ezetimibe in pharmaceutical formulations by liquid chromatography. Journal of Food and Drug Analysis, 2007. 15(2).
- Seshachalam, U. and C.B. Kothapally, HPLC analysis for simultaneous determination of atorvastatin and ezetimibe in pharmaceutical formulations. Journal of Liquid Chromatography and Related Technologies, 2008. 31(5): p. 714-721.
- Godse, V., et al., A RP-HPLC Method for Simultaneous Estimation of Atorvastatin and Ezetimibe in Pharmaceutical formulation. International Journal of Chemical Sciences, 2009. 7(3).
- Dhaneshwar, S., et al., Development and validation of a method for simultaneous densitometric estimation of atorvastatin calcium and ezetimibe as the bulk drug and in tablet dosage forms. Acta Chromatographica, 2007. 19: p. 141.
- Saroj Kumar Raul, Durgasi Jhansi RP-HPLC method development and validation for the simultaneous estimation of atorvastatin and ezetimibe in pharmaceutical dosage form. Asian Journal of Pharmaceutical and Clinical Research 2015. 8(2).
- Baldha R. G. Simultaneous Spectrophotometric Determination of Atorvastatin Calcium and Ezetimibe in Tablet Dosage Form International Journal of Chem Tech Research 2009. 1(2): p. 233236.
- Shivshanker, K., et al., Validated simultaneous estimation of simvastatin and ezetimibe by RP-HPLC in pure and pharmaceutical dosage form. Asian Journal of Chemistry, 2007. 19(6): p. 4303.
- Jain, N., et al., Spectrophotometric method for simultaneous estimation of simvastatin and ezetimibe in bulk drug and its combined dosage form. Internet J. Pharmacy Pharm. Sci, 2009. 1(1): p. 170-175.
- Krishnaveni, G. and P. Sathyannarayana, Method development and validation for simultaneous determination of ezetimibe and simvastatin in combined pharmaceutical dosage form by RPHPLC method. International Journal of Pharmaceutical and Life Sciences, 2013. 2(2): p. 60-69.
- Rahman, M., et al., Simultaneous estimation of simvastatin and ezetimibe in pharmaceutical tablet dosage forms by RP-HPLC: A Review. Int J Pharm Res Dev, 2010. 2: p. 56-62.
- Sama, J., et al., Simultaneous estimation of simvastatin and ezetimibe in pharmaceutical formulations by RP-HPLC method. J. Pharm. Sci. Res, 2010. 2(2): p. 82-89.
- Neelima, B., et al., Simultaneous estimation of simvastatin and ezetimibe by RP-HPLC in pure and pharmaceutical dosage form. Oriental Journal of Chemistry, 2008. 24(1): p. 195.
- Kumar, D.A., et al., Simultaneous determination of simvastatin and ezetimibe in tablets by HPLC. Journal of Chemistry, 2009. 6(2): p. 541-544.
- Amit Goel, S.B., Jasjeet K. Sahni, Kona S. Srinivas, Ravi S. Gupta, Abhishek Gupta, Vinod P. Semwal and Javed Ali, Development and Validation of Stability-Indicating Assay Method by UPLC for a Fixed Dose Combination of Atorvastatin and Ezetimibe. Journal of Chromatographic Science 2013. 51: p. 222-228.
- Mane, V.B., S. Babar, and N. Kulkarni, Development of UV spectrophotometric method for the simultaneous estimation of simvastatine and ezetimibe in tablet dosage form by simultaneous equation and absorbance ratio method. International Journal of Pharm Tech Research, 2011. 3(3): p. 1459-1466.
- B. Stephen Rathinaraj, V.R., Ch .Rajveer, D.Kumaraswamy, Ganesh Shehraobanglae, A. Arunachalam Development and Validation of A HPTLC Method for the Estimation of Simvastatin and Ezetimibe.. International Journal of Pharmaceutical and Biological Archives, 2010. 1(4): p. 325-330.
- Development and Validation of RP-HPLC Method for Simultaneous Estimation of Ezetimibe and Glimepiride in Tablet Dosage Form
Abstract Views :239 |
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Authors
Affiliations
1 MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 42200, IN
1 MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik – 42200, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 3 (2017), Pagination: 185-188Abstract
A simple, accurate and precise RP-HPLC method was developed and validated for simultaneous estimation of glimepiride (GLM) and ezetimibe (EZE) in tablet dosage form. Both drugs were separated on C18 Phenomenex column (250 × 4.6 mm, 5 μ) using methanol: 20mM potassium phosphate buffer (pH 3.00) (80: 20 % v/v) at flow rate of 1 mL/min. All eluents were detected at 230 nm. GLM and EZE were eluted at 5.292 and 4.183 min, respectively. The method was linear in the range of 2-10 μg/mL and 20-100 μg/mL for GLM and EZE, respectively. The developed method was further validated as per ICH Q2(R1) guidelines and applied successfully for the quantitation of tablet dosage form.Keywords
Ezetimibe and Glimepiride, RP-HPLC, Analytical Method Validation.References
- Anthony C Moffat, M.David Osselton and Barian Widdop, Clarke's Analysis of Drug and Poision.3rd edition 2: p.1080.
- Indian Pharmacolopoeia. (2014). 7 ed: Indian Pharmacopoeial Commission 2014.
- Saito, I., et al., A randomized, double-blind, placebo-controlled study of the effect of Ezetimibe on glucose metabolism in subjects with type 2 diabetes mellitus and hypercholesterolemia. Lipids in Health and Disease, 2015,14(1): p. 40.
- B.Siddartha and Radhika Malipelli, Simultaneous Estimation and Validation of Ezetimibe and Glimepride in Bulk and Pharmaceutical Dosage Form By RP-HPLC International journal of Research and Development in Pharmacy and Life Sciences, 2014, 3(6)(3): p. 1280-1286.
- T. Sonwjanya Jyothi, P.Nagaraju, Simultaneous Quantification and Validation of Glimepride and Ezetimibe By RP-HPLC in Bulk and Pharamcetutical Dosage Form, 2(3): p.1-5.
- Sudheer Kumar N, Shilpa K, Ajitha A , Uma Maheswara Rao V Method Development and Validation of Simultaneous Estimation of Ezetimibe and Glimepiride By RP-HPLC International journal of Pharmaceutical Research and Analysis, 2016, 6(1): p.47-52.
- Pavani, P., A. Srilekha, and B. Sreedhar, Stability indicating RPHPLC method development and validation for simultaneous estimation of glimepiride and ezetimibe in bulk and tablet dosage form. International Journal of Pharmaceutical Sciences and Research, 2015, 6(3): p. 1066.
- Hanifa Begum, S.H. Rizwan, Khaled Bin Sayeed Stability Indicating Analytical Method Development and Validation For Estimation of Ezetimibe and Glimepiride Using RP- HPLC Method in Bulk Drugs and Marketed Fromulation.Indo American Journal of Pharmaceutical Research, 2014,Vol 4, (Issue 10).
- Validation of Analytical Procedures: Text and Methodology, Q2R1, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonized Triplicate Guidelines 2005.
- Comparison Study of Conventional and Microwave Assisted Force Degradation by RP-HPLC Method of Pharmaceutical Drug and Dosage Form
Abstract Views :720 |
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Authors
Affiliations
1 Department of Pharmaceutical Chemistry, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon Nashik, Maharashtra, IN
2 MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra State 422003, IN
1 Department of Pharmaceutical Chemistry, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon Nashik, Maharashtra, IN
2 MET’s Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, Maharashtra State 422003, IN
Source
Asian Journal of Pharmaceutical Analysis, Vol 7, No 4 (2017), Pagination: 218-224Abstract
Comparison Study of conventional and Microwave assisted Force Degradation by using RP- HPLC was carried for determination of Piracetam in film coated tablets. A Grace C18 (250mm x 4.6ID, Particle size: 5 micron)RP- 18 column with a mobile phase consisting of Methanol: Water(20:80v/v) was used. Microwave assisted Force Degradation was performed acid, alkali, wet heat, oxidative and dry heat degradation study to prove that similar degradation product using microwave oven reduced time as compared to conventional. Quantitative evaluation was performed at 205 nm. The HPLC method is selective, precise and accurate and can be used for routine analysis of preparations in pharmaceutical industry quality control laboratories.Keywords
RP-HPLC, Force Degradation, Microwave and Piracetam.References
- V. Masarskal Analytical Method Development and Validation For Piracetam In Pharmaceutical Formulation Pharmacia, vol. 60, No. 4/2013
- Sushil D. Patil, Sunil V. Amurutkar and C. D. Upasani Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin Asian J. Pharm. Ana. 2016,Vol. 6; Issue 4
- Manutosh Acharya1, A.K Jain, et al RP-HPLC Method Development And Validation For Simultaneous Determination of Citicoline And Piracetam In Pharmaceutical Dosage Form Indo American Journal of Pharmaceutical Research, 2015, Vol 5, Issue 08, 3639-3647.
- Bhowmick Anindita A., Khandelwal, et al Analytical Method Development and Validation for Piracetam as Bulk and in Pharmaceutical Formulation International Journal of Pharm Tech Research.2010,Vol.2, No.1, pp 201-204
- Sonwane S.S et al Microwave Assisted forced degradation and development of a validated stability-indicating RP-HPLC method for Venlafaxine in bulk and capsule formulation Indian Drugs,2016,53(2),47-51
- International Conference on harmonization. Guideline on Validation of Analytical Procedure. Text and Methodology. ICH – Q2 (R1); 2005.
- Bakshi, Monika, and Saranjit Singh. "Development of Validated Stability-Indicating Assay Methods—Critical Review." Journal of Pharmaceutical and Biomedical Analysis 2002, 28.61011-40.
- Snyder L.R., Kirkland J. and Glajch J. (1997) Practical HPLC Method Development, 2nd ed. New York: John Wiley and Sons.
- Government of India, Indian Pharmacopoeia Commission Ministry of Health and Welfare (2007) Indian pharmacopoeia, Ghaziabad India
- Hong, Donald H., and Mumtaz Shah. "Development and Validation of HPLC Stability Indicating Assays." Drug Stability Principles and Practices. Ed. Christensen, Jens Thurø. 3 ed. New York: M. Dekker, 2002. 329-84.
- Q1BICH. "Photo stability Testing of New Drug Substances and Products Q1B." International Conference on Harmonization. Geneva: ICH, 1996.
- Q2 (R1)ICH. "Validation of Analytical Procedures: Text and Methodology Q2 (R1)."International Conference on Harmonization. Geneva: ICH, 2005.
- Synthesis and Evaluation of Antidiabetic Activity of Few 5-(4-(5-Substitutedphenyl)-1,3,4-Oxadiazlole-2-Yl) Methoxy)Benzylidene) Thiazolidine 2,4-Dione Derivatives
Abstract Views :523 |
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Authors
Affiliations
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, Savitribai Phule Pune University, IN
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, Savitribai Phule Pune University, IN
Source
Asian Journal of Pharmaceutical Research, Vol 7, No 4 (2017), Pagination: 261-264Abstract
The aim of study was to synthesize a new series of Thiazolidinedione. Thiazolidinedione or glitziness forms a significant class of drug which exhibit biological activities ranging from antidiabetic, antiinflamatory, antibacterial, antifungal, antiviral, and anti-cancer. In the present study reported a systematic synthesis of thiazolidinedione. A new series of 2,4-thiazolidinedione based derivative have been synthesize by condensation of. The structure of these compounds were establish by IR and 1H NMR. These new compound (C1-C4) were evaluated for their antidiabetic activity on albino rat. Most of compound shows significant antidiabetic activity when compare with standard drug metformin.Keywords
Diabetic Mellitus, Thiazolidinedione, Antidiabetic Activity.References
- Mohd Javed Naim, Ozair Alam and Farah Nawaz RECENT TARGET BASED DISCOVERY OF ANTI-DIABETIC AGENTS India International Journal of Pharmaceutical Sciences and Research.
- Mohd Imran, deepanjali, suroor ahamd khan. Recent thiazolidinedione antidiabetic. Journal of scientific and industrial research vol 1 66 2007 February pp 99- 109.
- Prashant B Mane, Rishikesh V Antre and Rajesh J Oswal. Antidiabetic Drugs: An Overview. INTERNATIONAL JOURNAL OF PHARMACEUTICAL AND CHEMICAL SCIENCES.
- Swapana D, Shivagami B, Manasa K. Synthesis ans evaluation of novel thiazolidinedione derivative of antidiabetic activity. International Research Journal of Pharmacy.
- Rekha. S, Shantaram. U. SYNTHESIS AND EVALUATION OF NOVEL THIAZOLIDINEDIONES FOR ANTI DIABETIC ACTIVITY. International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 3, Suppl 5, 2011
- Shashikant R. Pattana, Prajact Kekareb, Ashwini Patilc, Ana Nikaljec, BS Kitturd the Synthesis of Novel 2,4-ThiazolidinedioneDerivatives with Antidiabetic Activity Kitturd Iranian Journal of Pharmaceutical Sciences Autumn 2009: 5(4): 225-230
- Daniel J. Toft a, Miles Fuller a, Matthew Schipma b, Feng Chena, Vincent L. Cryns c αB-crystallin and HspB2 deficiency is protective from diet-induced glucose intolerance: www.elsevier.com
- Donald McClain, Animal Models of Diabetic Complications Consortium Intraperitoneal Glucose Tolerance Testing (IPGTT) Version: 1.0
- Amy R. Blair, Nadia Deluca, Barbara C. Fam, and Joseph Proietto Am. Evaluating the glucose tolerance test in mice Sofianos And rikopoulos. J Physiol Endocrinol Metab 295: E1323–E1332, 2008
- Solubility Enhancement of Ritonavir by using Liquisolid Compact Technique
Abstract Views :277 |
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Authors
Affiliations
1 Department of Pharmaceutics, MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, Affiliated to Savitribai Phule Pune University (SPPU), Pune, IN
2 Adgaon, Nashik, Maharashtra, India, Affiliated to Savitribai Phule Pune University (SPPU), Pune, IN
1 Department of Pharmaceutics, MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, Affiliated to Savitribai Phule Pune University (SPPU), Pune, IN
2 Adgaon, Nashik, Maharashtra, India, Affiliated to Savitribai Phule Pune University (SPPU), Pune, IN
Source
Asian Journal of Pharmacy and Technology, Vol 7, No 4 (2017), Pagination: 189-201Abstract
Novel solubility enhancement technique; liquisolid compact technique is used in present research work. Ritonavir is poorly soluble drug was formulated using Avicel pH 102 and Aerosil 200 as carrier and coating material respectively. Solubility studies were conducted in different liquid vehicles, namely propylene glycol, span 20, PEG 400, tween 20, and PEG 200. From the result of saturation solubility study the liquisolid compacts were formulated using PEG 400 as non volatile vehicle. The ritonavir liquisolid formulations were obtained by allowing liquid vehicle with varying ritonavir concentration to get absorbed onto carrier and coating material taken at different ratio (R=5,10,15,20).Then the ritonavir liquisolid powder system evaluated for flow property determination and then compressed into tablet. Each batch of prepared ritonavir Liquisolid powder compact evaluated for Quality control tests, i.e. uniformity of tablet weight, uniformity of drug content, tablet hardness, friability test, disintegration and dissolution study. Optimized batch of Liquisolid powder compact evaluated for quality control test of tablet along with FTIR, DSC and PXRD study. The tableting properties of the liquisolid compacts were within the acceptable limits and in vitro drug release rate of LS compacts were distinctly higher as compared to directly compressible tablet and pure drug alone. This was due to an increase in wetting properties and surface of drug available for dissolution. FTIR study result indicates that there is no drug excipient interaction..DSC and PXRD study suggested loss of ritonavir crystallinity upon liquisolid formulation, it indicates that drug is held within the power substrate in a solubilized, almost molecularly dispersed state, which lead to enhanced drug solubility. From significant result of solubility of ritonavir, liquisolid technique would be promising solubility enhancement technique for various poorly soluble drugs.Keywords
Ritonavir, Liquisolid Compact, PEG 400, Carrier Material, Coating Material, Poorly Water Soluble Drugs.References
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- Formulation and Optimization of Silymarin Loaded PLGA Nanoparticle for liver targeting
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Authors
Affiliations
1 Department of Pharmaceutics, MET’s Institute of Pharmacy, Adgaon, Nashik, IN
2 Department of Pharmaceutics, MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, IN
3 MET’s Institute of Pharmacy, Adgaon, Nashik, IN
1 Department of Pharmaceutics, MET’s Institute of Pharmacy, Adgaon, Nashik, IN
2 Department of Pharmaceutics, MET’s Institute of Pharmacy, Adgaon, Nashik, Maharashtra, IN
3 MET’s Institute of Pharmacy, Adgaon, Nashik, IN
Source
Asian Journal of Pharmacy and Technology, Vol 7, No 4 (2017), Pagination: 209-220Abstract
The aim of present study was to prepare silymarin loaded PLGA polymeric nanoparticles for liver targeting by solvent evaporation method. Special attention was devoted to targeted drug delivery to liver and then the controlled release of drug from the polymeric nanoparticles. PLGA were employed as a bio-degradable polymer for targeting and controlled release of drug. The particle size of the resultant PN’s was mainly controlled by the agitation speed during the manufacturing process and polymer concentration. PLGA nanoparticles have the stability problem hence is PVA used as Surfactant as well as Stabilizing agent for the production of stable nanoparticles. Following particle size, zeta potential, and DSC and SEM analysis. The Silymarin nanoparticles were prepared with different ratio of polymer (PLGA), surfactant (PVA) and solvent (acetone) by using solvent evaporation method. The organic phase {drug + polymer (1:1, 1:3, 1:5) + solvent} was added to aqueous phase {water + PVA (1, 2, and 3 %)} and subjected for homogenization with different rpm. The formulation was heated with magnetic stirrer for evaporation of solvent for 2 hrs. After evaporation of solvent, the formulation was centrifuged and supernatant was collected by filtration and dried at room temperature. The formed nanoparticles were evaluated for particle size, entrapment efficiency and in vitro release. The Nanoparticle was obtained having Particle Size in between 422.4-294.3 nm. Entrapment Efficiency in between 74.30-99.8% and % drug release in between 73.53-98.67% which follows the sustained release behavior. From given Data it concludes that Nanoparticle containing PLGA exhibiting excellent sustained release characteristics and Entrapment efficiency and also Good particle Size. Hence After stability studies all formulations were found to be physically and chemically stable.Keywords
Silymarin, PLGA, Polymeric Nanoparticle, PVA, Control Release.References
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- Insulin Therapies:Current and Future Trends
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Authors
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1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, Savitribai Phule Pune University, IN
1 MET’S Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422003, Savitribai Phule Pune University, IN
Source
Asian Journal of Research in Pharmaceutical Sciences, Vol 7, No 4 (2017), Pagination: 189-196Abstract
Many patients with advanced type 2 diabetes mellitus (T2DM) and all patients with T1DM require insulin to keep blood glucose levels in the target range. The most common route of insulin administration is subcutaneous insulin injections. There are many ways to deliver insulin subcutaneously such as vials and syringes, insulin pens, and insulin pumps. Though subcutaneous insulin delivery is the standard route of insulin administration, it is associated with injection pain, needle phobia, lipodystrophy, noncompliance and peripheral hyperinsulinemia. Therefore, the need exists for delivering insulin in a minimally invasive or noninvasive and in most physiological way. Inhaled insulin was the first approved noninvasive and alternative way to deliver insulin, but it has been withdrawn from the market. Technologies are being explored to make the noninvasive delivery of insulin possible. Some of the routes of insulin administration that are under investigation are oral, buccal, nasal, peritoneal and transdermal. This review article focuses on the various insulin delivery techniques. This article has focused on different possible routes of insulin administration with its advantages and limitation and possible scope for the new drug development.Keywords
Diabetes Mellitus, Inhaled Insulin, Insulin Delivery, Oral Insulin, Technology, Closed-Loop System, Artificial Pancreas.References
- Garg, S. K., et al. (2013). Use of non-insulin therapies for type 1 diabetes, Mary Ann Liebert, Inc. 140 Huguenot Street, 3rd Floor New Rochelle, NY 10801 USA.
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- Rima B. Shah1, M. P., David M. Maahs, Viral N. Shah (2016). "Insulin delivery methods: Past, present and future " International Journal of Pharmaceutical Investigation 6(1).
- Fry, A. (2012). "Insulin Delivery Device Technology 2012: where are we after 90 years?" Journal of Diabetes Science and Technology 6(4): 947-953.
- Penfornis, A., et al. (2011). "Evolution of devices in diabetes management." Diabetes Technology & Therapeutics13(S1): S-93-S-102.
- Shah, R. B., et al. (2016). "Insulin delivery methods: Past, present and future." International Journal of Pharmaceutical Investigation 6(1): 1.
- Cohen, O., et al. (2009). "Improved glycemic control through continuous glucose sensor-augmented insulin pump therapy: prospective results from a community and academic practice patient registry." Journal of Diabetes Science and Technology 3(4): 804-811.
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- Shah, V. N., et al. (2014). Closed-loop system in the management of diabetes: past, present, and future, Mary Ann Liebert, Inc. 140 Huguenot Street, 3rd Floor New Rochelle, NY 10801 USA.
- A Review on:Quality by Design (QbD)
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Authors
Affiliations
1 Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik 423301, Savitribai Phule Pune University, Maharashtra, IN
3 MET’s Institute of Pharmacy, Adgaon, Nashik, 423301, Savitribai Phule Pune University, Maharashtra, IN
1 Department of Pharmaceutics, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik , ,423301, Savitribai Phule Pune University, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, MET’s Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik 423301, Savitribai Phule Pune University, Maharashtra, IN
3 MET’s Institute of Pharmacy, Adgaon, Nashik, 423301, Savitribai Phule Pune University, Maharashtra, IN
Source
Asian Journal of Research in Pharmaceutical Sciences, Vol 7, No 4 (2017), Pagination: 197-204Abstract
Quality by Design is the modern approach for quality of pharmaceuticals. Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design (QbD) principles for in-depth process understanding to ensure that product quality is built in by design. The purpose of this paper is to discuss the pharmaceutical Quality by Design and describe how it can be used to ensure pharmaceutical quality. Quality cannot be tested into products but quality should be built in by design. Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile [Target product profile (TPP), Target product Quality profile (TPQP) and identify Critical quality attributed (CQA).On the basis of this we can design the product formulation and the process to meet the product attributes. These leads to recognize the impact of raw material Critical material attributes (CMA), Critical process parameter (CPP), on the CQA’s and identification and source of variability. QbD is necessary in regulatory requirement, and to implement new concepts such as design space, ICH guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management, and FDAs process analytical technology (PAT)Keywords
Quality by Design (QbD), Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality Attributes (CQA), Process Analytical Technology (PAT).References
- Sangshetti JN, Zaheer Z, Mahaparale PR and Chitlange SS. Quality by design (QbD) in pharmaceuticals. Unique Publication, Aurangabad. 1st edition; 2015: 20
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- Development and Validation of Stability Indicating RP-HPLC Method for Piracetam
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Authors
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1 Department of Pharmaceutical Chemistry, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon Nashik, Maharashtra, IN
2 Savitribai Phule Pune University, Pune, Maharshtra state, IN
1 Department of Pharmaceutical Chemistry, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon Nashik, Maharashtra, IN
2 Savitribai Phule Pune University, Pune, Maharshtra state, IN
Source
Asian Journal of Research in Pharmaceutical Sciences, Vol 7, No 4 (2017), Pagination: 215-221Abstract
A simple, rapid and validated HPLC method was developed for determination of Piracetam in film coated tablets. A Grace C18 (250mm x 4.6ID, Particle size: 5 micron) RP-18 column with a mobile phase consisting of Methanol: Water (20:80v/v) was used. Quantitative evaluation was performed at 205 nm. The HPLC method is selective, precise and accurate and can be used for routine analysis of preparations in pharmaceutical industry quality control laboratories.Keywords
RP-HPLC, Force Degradation Study, Piracetam.References
- V. Masarskal Analytical Method Development and Validation For Piracetam In Pharmaceutical Formulation Pharmacia, vol. 60, No. 4/2013
- Sushil D. Patil, Sunil V. Amurutkar and C. D. Upasani Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin Asian J. Pharm. Ana. 2016,Vol. 6; Issue 4
- Manutosh Acharya1, A.K Jain, et al RP-HPLC Method Development And Validation For Simultaneous Determination of Citicoline And Piracetam In Pharmaceutical Dosage Form Indo American Journal of Pharmaceutical Research, 2015, Vol 5, Issue 08, 3639-3647.
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- Predicting the Anti-Inflammatory Activity of Novel 5-Phenylsulfamoyl-2-(2-Nitroxy) (Acetoxy) Benzoic Acid Derivatives using 2D and 3D-QSAR (kNN-MFA) Analysis
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Authors
Affiliations
1 Department of Pharmaceutical Chemistry, Bhujbal Knowledge City, MET’S IOP, Adgaon, Nashik-422003, IN
1 Department of Pharmaceutical Chemistry, Bhujbal Knowledge City, MET’S IOP, Adgaon, Nashik-422003, IN
Source
Asian Journal of Research in Pharmaceutical Sciences, Vol 7, No 4 (2017), Pagination: 227-234Abstract
The quantitative structure–activity relationship (QSAR) analyses were carried out for a series of new side chain modified 5-phenylsulfamoyl-2-(2-nitroxy) (acetoxy) benzoic acid derivatives to find out the structural requirements of their anti-inflammatory activities. The statistically significant best 2D QSAR models for anti-inflammatory activity having correlation coefficient (r2) = 0.897 and cross validated squared correlation coefficient (q2) = 0.701 with external predictive ability (pred_r2) = 0.390 were developed by multiple linear regression coupled with genetic algorithm (GA–MLR) and stepwise (SW–MLR) forward algorithm, respectively. The results of the present study may be useful on the designing of more potent analogues as antimalarial agents.Keywords
QSAR, 5-Phenylsulfamoyl-2-(2-Nitroxy) (Acetoxy) Benzoic Acid, Anti-Inflammatory, MLR, Genetic Algorithm.References
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- Objective Monitoring of Cardiovascular Biomarkers Using Artificial Intelligence (AI)
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Authors
Sahil Mahajan
1,
Heemani Dave
1,
Santosh Bothe
2,
Debarshikar Mahpatra
3,
Sandeep Sonawane
1,
Sanjay Kshirsagar
1,
Santosh Chhajed
1
Affiliations
1 METs Institute of Pharmacy, Bhujbal Knowledge City, Affiliated to SPPU Pune University, Nashik, Maharashtra, IN
2 IEDC SVKM’s NMIMS University, Shirpur, Dist. Dhule, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, Dadasaheb Balpande College of Pharmacy, Nagpur, Maharashtra, IN
1 METs Institute of Pharmacy, Bhujbal Knowledge City, Affiliated to SPPU Pune University, Nashik, Maharashtra, IN
2 IEDC SVKM’s NMIMS University, Shirpur, Dist. Dhule, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, Dadasaheb Balpande College of Pharmacy, Nagpur, Maharashtra, IN
Source
Asian Journal of Pharmaceutical Research, Vol 12, No 3 (2022), Pagination: 229 - 234Abstract
Different CVDs (CVD) are the leading wreak of mortality and disability worldwide. The pathology of CVD is complex; multiple biological pathways have been involved. Biomarkers act as a measure of usual or pathogenic biological processes. They play a significant part in the definition, prognostication, and decision-making with respect to the treatment of cardiovascular events. Inthis article, we had summarized key biomarkers which are essential to predict CVDs. We had studied prevalence, pattern of expression of biomarkers (salivary, inflammatory, oxidative stress, chemokines, antioxidants, genetic, etc.), its measurable impact, benefits of early detection and its scope. A Considerable number of deaths due to cardiovascular diseases (CVDs) can be attributed to tobacco smoking and it rises the precarious of deathfrom coronary heart disease and cerebrovascular diseases. Cytokines which is categorized into pro inflammatory and anti-inflammatory take part in as biomarkers in CHD, MI, HF. Troponin, growth differentiation factor-15(GDF-15), C-reactive protein, fibrinogen, uric acid diagnose MI and CAD. Matrix Metalloproteins, Cell Adhesion Molecules, Myeloperoxidase, Oxidative stress biomarkers, Incendiary biomarkers are useful to predict the risk of UA, MI, and HF. Increased Endothelin-1, Natriuretic peptides, copeptin, ST-2, Galectin-3, mid-regional-pro-adrenomedullin, catecholamines are used to prognosticate Heart failure. Modern technologies like Artificial Intelligence (AI), Biosensor and high-speed data communication made it possible to collect the high-resolution data in real time. The high-resolution data can be analyzed with advance Machine Learning (ML) algorithms, it will not only help to discover the disease patterns but also an real-time and objective monitoring of bio-signals can help to discover the unknown patterns linked with CVD.
Keywords
CVDs, Biomarkers, Artificial Intelligence, Machine Learning, Personalized medicine, MonitoringReferences
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