DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR EVOGLIPTIN AND METFORMIN IN BULK AND TABLETS

A combination of Metformin and Evogliptin 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 bulk and tablet dosage forms.The drugs were resolved on a C18 (150mm 4.6mm, 5) column using Acetonitrile: water (75:25 v/v) as the mobile phase.The detection wavelength was 226 nm.The retention times obtained for metformin and evogliptin were 1.187& 2.273 min respectively.The linearity ranges were 250-1250 & 2.5-12.5 g/ml respectively with Regression coefficients of 0.9974 & 0.9994.The % RSD of precision studies was found to be less than 2%.The Accuracy of the proposed method was determined by recovery studies and the mean recovery was found to be in between 98-102%.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.