ABSTRACT:
A simple, sensitive, accurate, rapid and economical RP-HPLC method was developed for estimation of Sotagliflozin in pure drug and tablet dosage form. The absorbance was measured at 274nm using distill methanol ethanol water as solvent system. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness. It was also found that the excipients present in the commercial formulation did not interfere with the method. The proposed method can be utilized for routine quantitative analysis of Sotagliflozin.
Cite this article:
Husnain Fathima, Syed Sagheer Ahamed. Estimation and Validation of Sotagliflozin in Dosage Form and Bulk Drug by RP-HPLC Method. Asian Journal of Research in Chemistry.2026; 19(6):529-2. doi: 10.52711/0974-4150.2026.00075
Cite(Electronic):
Husnain Fathima, Syed Sagheer Ahamed. Estimation and Validation of Sotagliflozin in Dosage Form and Bulk Drug by RP-HPLC Method. Asian Journal of Research in Chemistry.2026; 19(6):529-2. doi: 10.52711/0974-4150.2026.00075 Available on: https://ajrconline.org/AbstractView.aspx?PID=2026-19-6-2
7. REFERENCES:
1. Cephalon C A, Cinti F, Moffa S, Impronta F. Sotagliflozin the first dual SGLT inhibitor: current outlook and perspectives. Bio med Chem. 2019:1-14.
2. Zhou F, Du N, Zhou L, Wang C. The safety of Sotagliflozin in the therapy of diabetes mellitus type 1 and type 2: A mere analysis of randomised trials. Pharma. Med Chem. 2022; 26:1-15.
3. Ioannis A, Thomas K, Panagiota K, Theodoros M. Sotagliflozin for patients with type 2 diabetes: A systematic review and meta-analysis. Diabetes Obesity and Metabolism. 2021;24(1):106-14
4. Sotagliflozin internet cited JAN 2023 Available from https://pubchem.ncbi.nlm.nih. gov /compound/Sotagliflozin https://www.selleckchem.com/products/finerenone.html
5. Lalitha P, Sachithanandam V, Swarnakumar S N, Sridhar R, Review on Anti-inflammatory Properties of Mangrove plants. Asian Journal of Pharmaceutical Research. 2019; 9(4): 273-288
6. M Sreejith, N Kannappan, A Santhiagu, M P Ajith, Analgesic and anti-inflammatory activities of aerial parts of Flacourtia sepiaria Roxb. Asian Journal of Research in Pharmaceutical Sciences. 2015; 5(1): 12-17
7. Navale G, D P Dipak, A P Aashutosh, B P Ketan, B P Narendra, Membrane Stabilization assay for Anti-inflammatory activity yields misleading results for samples containing traces of Methanol. Asian Journal of Pharmaceutical Research. 2019; 9(3): 169-171
8. D P Jayesh, R Amitkumar, Dhankani, Pawar P Sunil, Spectrophotometric and Chromatographic Review on NSAIDs include: Zaltoprofen, Loxoprofen, Ketoprofen and Flurbiprofen. Asian Journal of Pharmaceutical Analysis. 2023; 13(4): 261-6
9. Singh P, Sharma D, S Akanksha, G Himanshu, S Arjun, Biological screening to identify hits the Therapeutic Targets of Alzheimer's disease and their role in the pathogenesis. Asian Journal of Research in Chemistry. 2024; 17(1): 45-49
10. Muthubhupathi M, Selvakumar M, Shree N S, Nisha C, Priya P S, Varshini A P, Design, Synthesis, Characterization and Non-steroidal Anti-Inflammatory Activity of Novel Oxazolone Derivatives. Asian Journal of Pharmaceutical Research. 2023; 13(3): 145-152
11. 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
12. 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
13. Harikrishnan N, MuraliKrishna U, Shaik B, Bhavsar V, V Manjusha, Kumar RV. Development and Validation of UV-Spectrophotometric Method of Glibenclamide (Glyburide) in Bulk and Pharmaceutical Formulations. Asian Journal of Research in Chemistry. 2010; 3(2): 316-318
14. 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. Asian Journal of Pharmaceutical Research. 2021; 11(2)?: 57-62
15. Patel K K, Patel M A, Patel N C. A new simple RP-HPLC method development, Validation and Forced degradation studies of Bilastine. Asian Journal of Research in Chemistry. 2021; 11(3): 183-187