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Sonawane, Sandeep
- Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin HCl and Gliclazide
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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 and Validation of RP-HPLC Method for Simultaneous Estimation of Telmisartan, Amlodipine Besylate and Hydrochlorthiazide in their Tablet Dosage Form
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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
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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 :183 |
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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.