A New Validated Stability Indicating RP-HPLC Method for Simutaneous Estimation of Metformin Hydrochloride and Empagliflozin in Tablet Dosage Forms

A combination of Metformin HCl and Empagliflozin is used to treat type 2 diabetes mellitus. A selective, accurate and precise RPHPLC method was developed and validated for simultaneous estimation of these drugs in combined tablet dosage forms. The drugs were resolved on a Kromosil C18 column using Acetonitrile: 0.1% orthophosphoric acid (50:50 v/v) as the mobile phase. The detection wavelength was 260 nm. The retention times obtained for metformin HCl and empagliflozin were 2.192 & 3.200 min respectively. The linearity ranges were 125-750 & 1.25-7.5 µg/ml respectively with Regression coefficients of 0.999. The % R.S.D. of precision studies was found to be 0.57 & 0.44 respectively. The Accuracy of the proposed method was determined by recovery studies and the mean recovery was 100.55 & 100.52% respectively. The method was also applicable for quantitative analyses of the marketed tablet formulations and in studying stability of the drugs under acidic, alkaline, oxidation, thermal and UV conditions