Refine your search
Collections
Year
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Fathima, Husnain
- Estimation and Validation of Remogliflozin Etabonate in Dosage form and in Bulk Drug by Spectrophotometeric Method
Abstract Views :70 |
PDF Views:0
Authors
Affiliations
1 Department of Pharmaceutical Chemistry, MMU College of Pharmacy, Ramanagar - 562159 Karnataka, India, IN
1 Department of Pharmaceutical Chemistry, MMU College of Pharmacy, Ramanagar - 562159 Karnataka, India, IN
Source
Asian Journal of Research in Chemistry, Vol 15, No 2 (2022), Pagination: 166 - 170Abstract
A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Remogliflozin Etabonate in pure drug and tablet dosage form. The absorbance was measured at 239.8nm using Ethanol as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml with coefficient of correlation (r2) of 0.997. Limit of detection (LOD) was found to be 1.220µg/ml and Limit of quantitation (LOQ) was found to be 5.220µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.Keywords
Remogliflozin Etabonate, Type II diabetes, Spectrophotometry, Ethanol, Method validation
References
- Statement on a nonproprietory name adopted by the USAN council
- "Avolynt Announces Completion of Phase 2b BRID Study of SGLT2 Inhibitor Remogliflozin-Etabonate" (Press release). Avolynt, Inc. Retrieved July 24, 2018.
- S Mudaliar, AD Armstrong, AA Mavian, R Semmes Connor O, KP Mydlow, J Ye, et al. (November 2012). "Remogliflozin Etabonate, a selective inhibitor of the sodium-glucose transporter 2, improves serum glucose profiles in type I diabetes". Diabetes Care. 35 (11): 2198–200. doi:10.2337/dc12-0508. PMC 3476920.PMID 23011728.
- RL Dobbins, R Semmes Connor O, A Kapur, C Kapitza, G Golor, I Mikoshiba, et al. (January 2012). "Remogliflozin Etabonate, a selective inhibitor of the sodium-dependent transporter II reduces serum glucose in typeII diabetes mellitus patients". Diabetes, Obesity and Metabolism. 14 (1): 15–22. doi:10.1111/j.14631326.2011.01462.x. PMID 21733056.S2CID 23372554.
- PA Sykes, R Semmes Connor O, R Dobbins, JD Dorey, DJ Lorimer, S Walker, et al. (January 2015). "Randomized trial showing efficacy and safety of twice-daily Remogliflozin Etabonate for the treatment of type II diabetes". Diabetes, Obesity and Metabolism. 17 (1): 94–7. doi:10.1111/dom.12391. PMID 25223369.S2CID 6436562.
- PA Sykes, LG Kemp, R Dobbins, R Semmes Connor O, RS Almond, OW Wilkison, et al. (January 2015). "Randomized efficacy and safety trial of once-daily Remogliflozin Etabonate for the treatment of type II diabetes". Diabetes, Obesity and Metabolism. 17 (1): 98–101. doi:10.1111/dom.12393. PMID 25238025.S2CID 25280330.
- "Molecule of the Month: Dapagliflozin". Prous Science. November 2007. Archived from the original on January 6, 2008.
- S Nakano, K Katsuno, M Isaji, T Nagasawa, B Buchrer, S Walker, W O Wilkison, B Cheatham. Journal of Clinical and Experimental Hepatology, 2015;5(3):190-198
- Y Fujimori, K Katsuno, I Nakashim. Remogliflozin Etabonate, in a novel category of selective low-affinity sodium glucose cotransporter (SGLT2) inhibitors, exhibits antidiabetic efficacy in rodent models. J. Pharmacol. Exp. Ther. 2008;327(1):268-276
- Vidhi D, Patel P. Method development and validation of UV spectrophotometric estimation of Remogliflozin Etabonate in bulk and its tablet dosage form. Research Journal of Pharmacy and Technology. 2021;14(4):2042-2044
- Swapna J, Madhu C, Srivani M, Sumalatha M, Nehalatha Y, Anusha Y. Analytical method Development and Method Validation for the Simultaneous Estimation of Metformin Hydrochloride and Pioglitazone Hydrochloride in Tablet Dosage Form by RP-HPLC, Asian Journal of Pharmaceutical Analysis.
- ;2(3):85-89
- Vichare V, Suryawanshi P, Bhosale J, Dhole S. Simultaneous estimation of Metformin HCl and Pioglitazone HCl by Second Order Derivative UV- Visible Spectrophotometric Method in Tablet Formulation, Asian Journal of Pharmaceutical Analysis.2014;4(3):121-124
- Sri VK, Anusha M, Reddy RS. A rapid RP-HPLC Method Development and Validation for the Analysis of Linagliptinin Bulk and Pharmaceutical Dosage Form, Asian Journal of Pharmaceutical Analysis, 2015;5(1):16-20
- Pawar J, Sonawane S, Chhajed S, Kshirsagar S. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin HCl and Gliclazide, Asian Journal of Pharmaceutical Analysis. 2016; 6(3):151-154
- Rao VB, Vijetha P, Vidyadhara S, Kavita K. A Novel RP-HPLC Method Development and Validation for the Determination of Pioglitazone and Glimepride in Bulk and Pharmaceutical Formulations, Asian Journal of Pharmaceutical Analysis. 2017; 7(3): 145-150
- Gadge SS, Nakod DA, Wasnik PV, Gatkine MT, Zile SS, Mohije HN, Salode LV. Development and Validation of Q-absorbance Ratio method for Simultaneous Estimation of Teniligliptin hydrobromide and Metformin HCl in Multicomponent Dosage form. Asian Journal of Pharmaceutical Analysis, 2019; 9(4): 215218
- Venkatesh S, Jyothi S, Chiluka R, Padmavati Y. Development of UV-Spectrophotometric Method for the Simultaneous Estimation of Nateglinide and Piperine in combined tablet dosage form. Asian
- Journal of Pharmaceutical Analysis. 2020; 10(3): 134-140
- Farkade K, Tawar M. Analytical Method Validation and Quantitative Analysis for Active Pharmaceutical Ingredient and Marketed Formulation of Teniligliptin Hydrobromide by UV Spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021; 11(3): 195-8
- More SS, Sonawane SS, Chhajed SS, Kshirsagar JS. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Saxagliptin and Dapagliflozin in Tablets. Asian Journal of
- Pharmacy and Technology. 2018; 8(3):145-148
- Harikrishnan N, Murali Krishna U, Shaik B, Bhavsar V, V Manjusha, Kumar RV. Development and Validation of UVSpectrophotometric Method of Glibenclamide (Glyburide) in Bulk and Pharmaceutical Formulations. Asian Journal of Research in
- Chemistry. 2010; 3(2): 316-318 .
- Estimation of Ibrutinib in Dosage Form and in Bulk Drug by UV Spectrophotometric and Colorimetry Methods
Abstract Views :61 |
PDF Views:0
Authors
Affiliations
1 Department of Pharmaceutical Chemistry, MMU College of Pharmacy, Ramanagar - 562159 Karnataka, India., IN
1 Department of Pharmaceutical Chemistry, MMU College of Pharmacy, Ramanagar - 562159 Karnataka, India., IN
Source
Asian Journal of Research in Chemistry, Vol 15, No 4 (2022), Pagination: 245 - 250Abstract
A simple, sensitive, accurate, rapid and economical Spectrophotometric and colorimetric methods was developed for estimation of Ibrutinib in pure drug and tablet dosage form. The absorbance was measured at 248nm and 552nm using ethanol as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml and 1- 5µg/ml with coefficient of correlation (r2 ) of 0.998 and 0.996. Limit of detection (LOD) was found to be 1.226µg/ml and1.000µg/ml Limit of quantitation (LOQ) was found to be 5.226µg/ml and 2.760µg/ml. The proposed analytical methods were validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggednessKeywords
Ibrutinib, Anti-tumor drug, Spectrophotometry, Colorimetry, Ethanol, BMR, Method Validation.References
- A.L Honig berg, Smith, A.M., Sirisawad, M., et al. Proc. Natl. Acad. Sci. USA107(29), 13075-13080 (2010).
- M.E.S Herman, AL Gordon, E Hertlein, et al. Blood117(23), 62876296(2011).
- MWu A, Akinleye and Zhu, Hemato lJX Oncol.6, 36(2013)
- https://en.m.wikipedia.org/wiki/Ibrutinib
- https://go.drugbank.com/drugs/DB09053
- Santhosillendula, Priyanka D, Shirisha V, Rao V N K, Dutt R new simple method development and validation of a Ibrutinib in bulk and pharmaceutical dosage for by RP-HPLC. International Journal of Pharmaceutical and Biological Sciences 2019; 9(1): 36-46
- Uppala V, Tabassum A, Lavanya K, Neerja V, Sharma JVC. Method development and validation of ibrutinib by RP-HPLC in bulk and pharmaceutical dosage form. World J Pharm and Pharm Sci; 2016,5(5):868-874.
- National Cancer Institute. Chronic lymphocytic leukemia treatment; 2019.
- Byrd JC, Furman RR, Coutre SE, Flinn JW, Kristie AB. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia; N Engl JMed2013; 369(1), 32-42.
- Shaywitz, David. The wild story behind a promising experimental Cancer Drug; 2013.
- Agarwal MB, Bhurani D, Shah C, Sood N, Singhal M, Kamat A, Chezhian S, Mishra S, Nagrale D. Efficacy and safety of ibrutinib in Indian patients with relapsed or refractory chronic lymphocytic leukemia and mantle cell lymphoma: cases from a named patient program. Indian J Med Pediatr Oncol 2017; 38(4): 508-515.
- https://pubchem.ncbi.nlm.nih.gov/compound/Ibrutinib#section=Dissoci ation-Constants
- https://reference.medscape.com/drug/imbruvica-ibrutinib-999896
- Instrumental Analysis, Skoog, fifth edition, page no.312-316
- Instrumental Methods of Chemical Analysis, Chatwal. R. Gpageno 2.116-2.122
- Elementary Organic analysis, Principles and Chemical application, Sharma R.Y, page no 12-14
- A Text Book of Pharmaceutical Analysis, V. Akasturi, vol 310thed., 169-81
- https://pubchem.ncbi.nlm.nih.gov/compound/Ibrutinib
- Owen T, Text Book of Fundamentals of UV-Visible spectroscopy1139
- http://www.cem.msu.edu/~reusch/virtualtext/spectrpy/UVVis/uvspec.h tm#uv1
- U.S. Pharmacopoeia (USP) general chapter $1226%, verification of compendial procedures, USP, Rockville, MD
- U.S Pharmacopoeia (USP) general chapter $1225%, validation Of compendia procedures, USP, Rockville, MD
- International Conference on Harmonization (ICH) (1999, Oct), harmonized tripartite guidelines Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical Substances.
- International Conference on Harmonization (ICH) (2000, Nov), Harmonized Tripartite guidelines Q7A GMP for active Pharmaceutical Ingredient.
- International Conference on Harmonization (ICH) (2005, Nov), Harmonized Tripartite Guidelines Q2(R1), Validation of Analytical Procedures; Text and Methodology.
- International Conference on Harmonization (ICH) (2006, Sept), guidance for industry: Quality Systems Approach to Pharmaceuticals cGMP.
- Chung Chow Chan; analytical method validation; principles and practices; Azopharma Contract pharmaceutical services, Miramar, Florida.
- Code of Federal Regulations (CFR,), Part 211, current good manufacturing practice for finished pharmaceuticals.
- Chann, C.C et.al (2004), analytical method validation and instrument performance verification, Jwiley, Hoboken, NJ.
- Byrd JC, Brown JR, O’Brien S, Barrientos JC. Ibrutinib versus of atumumabin previously treated chronic lymphoid leukemia. N Engl JMed2014;371,213-223.
- Muneer S, Ahad HA, Bonnoth CK. Novel stability indicating analytical development and validation of RP-HPLC assay method for quantification of Ibrutinibin bulk and its formulation. J Pharm Res 2017; 11(6), 712-718.
- Bindu GH, Annapurna MM. a sensitive stability indicating RP-HPLC method for the determination of ibrutinib-Ananti-Cancer drug. Res J Pharm and Tech 2018; 11(10):4581-4591.
- Kim ES, Dhillon S. Ibrutinib: are view of its use in patients with mantle cell lymphomaorchronic lymphocytic leukemia. Drugs. Pub Med. 75(7); 2015:769-776.
- Parmar S, Patel K, Ibarz JP. Ibrutinib (Imbruvica): An ovel targeted therapy for chronic lymphocytic leukemia. Pharm and Therapeutics 2014; 39(7):483-87.
- Herman SEM, Nieman CU, Farooqui M, Jones J, Mustafa RZ, Lipsky A, Saba N, Martyr S, Soto S, Valdez J, Gyamfi JA, Maric I, Calvo KR, Pederson LB, Geisder CH, Liu D, Marti GE, Aue G, Wiestner A.
- Ibrutinib-induced lymphocytosis in patients with chronic lymphocytic leukemia: correlative analysis from a phase II study. Macmillan Publishers Ltd. Leukemia. 2014; 28:2188-96.
- Meloun. M, Mikesova. V, Pekarek. T, Javurek. M. The thermodynamic overlapping Pka of the antitumor drug Ibrutinib using multiwavelength UV/Visible spectroscopy and potentiometry. Journal of Analytical and Pharmaceutical Research 2(6); 2017:2-10
- Ezzddin. E, Iqbal. M, Herqash. N.R, Elnahhas. T. Simultaneous quantitative determination of seven novel tyrosine kinase inhibitors in plasma by a validated UPLC-MS/MS method and its application to human microsomal metabolic stability study. Journal Of Chromatography. B26 October 2019 1-8
- Rood. M.J.J, Sparidans. W.R. Bioanalysis of Ibrutinib, and its dihydrodiol and glutathionecy clemetabolites by liquid chromatography-tandem mass spectrometry. Journal of Chromatography. B2018:14-21
- Mehta. L, Mukherjee. DLC and LC-MS/MS studies for identification and characterization of new degradation products of ibrutinib and elucidation of their degradation pathway. Journal of Pharmaceutical and Biomedical Analysis.
- Yasu. T, Momo. K, Yasui. H, Kuroda. S. Simple determination of plasma ibrutinib concentration using high-performance Liquid Chromatography. Biomedical Chromatography.33(3)2019
- Veeraraghavan. S, Rangasamy. M. Simultaneous qualification of lenalidomide, ibrutinib and its active metabolite PCI-45227 in rat plasma by LC-MS/MS: application to a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis107(2015)151-158
- Ping. D, Guan. Y, Zhuoling. A, Pengfei. L, Lihong. LA selective and robust uplc-MS/MS method for the simultaneous quantitative determination of anlotinib, ceritinib and ibrutinib in rat plasma and its application to a pharmacokinetic study. Royal Society of Chemistry.144(18), 2019:5462-5471
- Beauvais. D, Goossens. F.J, Boyle E, Allal. B, Lafont. T, Chatelut. E, Herbaux. C, Morschhauser. F, Genay. S, Odour. P. Development and validation of an UHPLC-MS/MS method for simultaneous quantification of ibrutinib and its dihydrodiol-metabolite in human cerebrospinal fluid. Journal of chromatography B-Analytical Technologies in the Biomedical and Life Sciences. (2018)1093-1094
- Bende. G, Kollipara. S, Sekar. V, Saha. RUV-spectrophotometric determination of imatinib mesylate and its application in solubility studies. Original Studies. 63(2008) 641-645
- P. Ajithkumar, A. Smith. A. Development of analytical method for imatinib mesylate by Ultraviolet spectroscopy. Asian Journal of Pharmaceutical and Clinical Research. 1(13):2020; 180-183
- Haque. M, Bakhshi. V, Surekha. D, Gmuit. B, Reddy. P.H. Development of UV-spectrophotometric method for the determination of imatinib mesylate (ITM) in bulk and formulation. International
- Journal of Pharma Research and Health Sciences. 4(2):2016; 1130- 1135
- Roth. O, Varoquaux. S.O, Bouchet. S, Rousselot. P, Cstaigne. S, Rigaudeau. S, Ragguenear. V, Therond. P, Devillier. P, Molimard. M, Maneglier. B. Imatinib assay by HPLC with photodiode array UV
- detection in plasma from patients with chronicmyeloid leukemia. Clinica Chimicaacta 411(2010)140-146
- Bianchi. F, Savi. M. Development and validation of a high performance liquid chromatography-tandem mass spectrometry method for the determination of imatinib in rat tissues. Journal of Pharmaceutical and Biomedical Analysis. 73(2013); 103-107
- Madur. S, Matole. V, Kalshetti. M. UV Visible spectrophotometric method development and validation of dasatinib in bulk and solid dosage form. International Journal of Current Pharmaceutical
- Research. 4(12):2020; 90-93
- Jesus SH.C, Diculescu. C.V. Redox mechanism, spectrophotometrical characterization and voltammetric determination in serum samples of kinases inhibitors and anticancer drug dasatinib.752(2015);47-53
- Bhole. R, Bonde. C, Biradar. P. Development and validation of stability indicating HPTLC method for estimation of dasatinib and characterization of degradation products by using mass spectroscopy.
- Eurasian Journal of Analytical Chemistry 13(4):2018; 1306-3057
- Ramachandra. B, Naidu. N.V.S, Sekhar. K.C. Validation of RP-HPLC method for estimation of dasatinibin bulk and its pharmaceutical dosage forms. International Journal of Pharmacy and Biological
- Sciences. 4(1):2014;61-68
- Estimation and Validation of Bilastine in Pharmaceutical Dosage Form and in Bulk Drug by Spectrophotometric Method
Abstract Views :67 |
PDF Views:0
Authors
Affiliations
1 Department of Pharmaceutical Chemistry, M.M.U College of Pharmacy, Ramanagar - 562159 Karnataka, India ., IN
2 Department of Pharmaceutical Chemistry, M.M.U College of Pharmacy, Ramanagar - 562159 Karnataka, India., IN
1 Department of Pharmaceutical Chemistry, M.M.U College of Pharmacy, Ramanagar - 562159 Karnataka, India ., IN
2 Department of Pharmaceutical Chemistry, M.M.U College of Pharmacy, Ramanagar - 562159 Karnataka, India., IN
Source
Asian Journal of Research in Chemistry, Vol 15, No 4 (2022), Pagination: 279 - 283Abstract
A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Bilastine in pure drug and tablet dosage form. The absorbance was measured at 226.2nm using Methanol as solvent system. It obeyed Beer’s law at the concentration range of 2-12µg/ml with coefficient of correlation (r2) of 0.9993. Limit of detection (LOD) was found to be 1.224µg/ml and Limit of quantitation (LOQ) was found to be 4.088µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.Keywords
Bilastine, Antihistamine, Spectrophotometry, Methanol, method validation.References
- Wolthers O D. Bilastine : A new nonsedating oral H1 antihistamine for treatment of allergic rhinoconjuctivitis and urticaria. BMRI. 2013; Article ID 626837.
- Leceta A, Sologuren A, Valiente R, Campo C, and Labeaga L.Bilastine in allergic rhinoconjunctivitis and urticaria: a practical approach to treatment decisions based on queries received by the medical information department. Drug Context. 2017; 6:212500.
- Scaglione F. “Safety profile of bilastine : 2nd generation H1 antihistamines. ERMPS.2012;16(14):1999-2005.
- Lasseter KC, Sologuren A, La Noce A, Dilzer SC. Evaluation of the single-dose pharmacokinetics of bilastine in subjects with various degrees of renal insufficiency. Clinical Drug Investigation.
- ; 33:665-673.
- Berrueta LA, Fernandez-Armentia M, Bakkali M, Gonzalo A, Lucero ML. Matrix solid-phase dispersion technique for the determination of a new antiallergic drug bilastine in rat faeces. Journal of Chromatography B. 2001; 760:185-190.
- Amarendra CV, Anusha K, Muneer S. Method development and validation of new RP-HPLC method for the estimation of bilastine in pharmaceutical dosage form. WJPPS. 2017; 6(8):2297-2315.
- Terzic J, Popovic I, Stajic A, Tumpa A, Jancic-Stojanovic B. Application of analytical quality by design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. JPBMA. 2016; 125:385-393.
- ICH Q2 (R1). Validation of analytical procedures: text and methodology International Conference on Harmonization ICH, Geneva. 2005.
- Mali DA, Manojkumar P. Estimation of Rantidine in Bulk and Formulation by First Order Derivative Area Under Curve UVSpectrophotometry Methods. AJPA.2015; 5(2):61-66
- PP Pardeshi, MV Gaware, BK Dhamak. Development and Validation of RP-HPLC Method for the Estimation of Bilsatine from bulk and Formulation. AJPA.2020; 10(2):109-111
- S. Subramanya Raj Urs, Bindu M, Ramyashree D, Sowmya K N. Estimation of Cetirizine Hydrochloride in pharmaceutical preparation. AJPA.2020; 10(4)185-188
- A M Beltagi, I A Lashin, W A Essa, A A Hathoot, M. Abdel Azzem. Evolution and effectiveness of HPLC technique for rapid estimation of an antiallergic agent Bilastine. AJPA.2021; 11(2)5762
- Patel K K, Patel M A, Patel N C. A new simple RP-HPLC method development, Validation and Forced degradation studies of Bilastine.AJPA.2021; 11(3)183-187
- Harikrishnan N, R Deepthi, V Manjusha, Vani S P, Jyothi A V M. Development and Validation of UV spectrophotometric methods of Loratadine in bulk and pharmaceutical formulation. AJPA.2010; 3(2)305-307
- Harikrishnan N, Muralikrishna U, Vani S P, Jyothi AVM, Ranjithkumar V, Haribaskar. Development and Validation of UV spectrophotometric method of levocetirizine dihydrochloride in bulk and pharmaceutical formulation. AJPA. 2010; 3(3)539-541
- Agarwal P N, Teli E N. A validated and simplified RP-HPLC method for Estimation of Ebastine from bulk drugs. AJPA.2011; 4(7)1164-1167
- Sankar KSA, Baskar NG, Nagavalli D, Anandakumar K, Vetrichelvan T. Simultaneous Estimation of Montelukast Sodium and Levocetirizine hydrochloride from tablet dosage form. AJPA.2009; 2(4)743-745
- Choudhari PV, Kale NA, Polshettiwar AS, Sutar S A, Patel M D, Kuchekar SB. Derivative and Absorption factor Spectrophotometric estimation of Montelukast Sodium and Levocetirizine dihydrochloride from pharmaceutical formulation. AJPA. 2011; 4(3)389-392