ADVANCED METHODOLOGICAL ESTABLISHMENT OF STABILITY INDICATING ASSAY METHOD AND FORCED DEGRADATION STUDY OF DAPAGLIFLOZIN- DRUG HAVING ACTIVITY AGAINST METABOLIC DISORDERS BY USING RP-HPLC TECHNIQUE

Abstract

It is a faster, precise and accurate method of analysis for Dapagliflozin using HPLC.  This method includes Thermo scientific BDS C18 Hypersil (150cm × 4.6 mm, 5 µ) column, Mobile phase solution A: 0.1% OPA in Water (100%), Mobile phase solution B: ACN: Methanol (40:60 %V/V) and mixture of A: B in the proportion of (40:60 %v/v) at wavelength of 224 nm. The linearity, accuracy, precision, and robustness of this method were all confirmed. The range of linearity was discovered 20-60µg/mL & The correlation coefficient value was 0.999. The precision and robustness of this method was proven hence percent RSD was found less than 2%.  The percentage recovery was in the range of 99.35-101.54%. LOD and LOQ were 11.75 S/N and 20.81 S/N. To evaluate the stability indicating properties degradation study by exposed with Acid (3 N HCL in a temperature range of 80°C) 3.97%, Base (3 N HCL in a temperature range of 80°C) 4.02%, A solution containing hydrogen peroxide (6% H2O2) 3.90%, Neutral for 1 hour 4.08%, UV light exposure at 294nm for 24 hours 3.02%, thermal degradation at 80oC for 1hr 3.90%.