Stability Indicating Analytical Method Development and Validation of Anti-Diabetic Drug Dapagliflozin Bulk
Keywords:
Dapagliflozin, Type 2 diabetes, RP-HPLC, Method Development, ValidationAbstract
An exceedingly effective, reversible, and particular inhibitor of sodium-glucose cotransporter-2, Dapagliflozin is affirmed for the treatment of type 2 diabetes (T2D) all through the world. It is given to people to improve glycaemic management. Type 2 diabetes mellitus (T2DM) is a chronic, progressive illness which has been recognised as a major health issue which is having a substantial impact on both life expectancy and medical costs. Blood glucose levels rise as a result of the disease's loss in beta cell activity. The present study is intended to develop and validate stability indicating validated RP-HPLC method for determining the oral anti-diabetic medication Dapagliflozin in bulk. A novel, simple, quick, accurate, precise and consistent RP-HPLC method was developed for the drug in study i.e. Dapagliflozin. The chromatographic separation of Dapagliflozin was achieved on RP-HPLC equipped with C18 (150 mm×4.6 mm, 5 μm) column. Mobile phase (Buffer Solution: ACN) composed of 55 volumes of buffer solution and 1.36 gram of potassium dihydrogen orthophosphate was dissolved in 1000 ml HPLC water and then pH was balanced utilizing weaken phosphoric acid to a pH of 2.0 and 45 volumes of acetonitrile. Then it was mixed well and sonicated to degas and then filtered. The retention time of the Dapagliflozin was found to be 3.38 with excellent absorbance sensitivity at 225 nm wavelength. The linear regression equation was found to be (y = 28916x + 16389) with a correlation coefficient R² = 1.0000 which shows excellent linear correlation. Specificity, linearity, precision, accuracy robustness, degradation was determined for method validation and results were found to be well within recommended limits as per ICH guidelines
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