DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF SAXAGLIPTIN AND METFORMIN HCL BY USING RP-HPLC METHOD

Abstract

A simple, rapid and selective HPLC method has been developed for quantitation of Saxagliptin and Metformin HCl from bulk drug and pharmaceutical formulations using a mobile phase consisting mixture of methanol and phosphate buffer pH-5.0 (70:30 v/v) at the flow rate of 1 ml/min. Waters C-8 (25 cm x 4.6 mm, 5 µm.) column was used as stationary phase. The retention time of Metformin HCl and Saxagliptin were 2.8 min. and 4.9 min. respectively. Linearity was observed in the concentration range of 2.5-12.5 µg/mL for Saxagliptin and 250-1250 µg/ml for Metformin HCl. Percent recoveries obtained for Saxagliptin and Metformin HCl were 102 and 101 respectively. The proposed method is precise, accurate, selective and rapid for the simultaneous determination of Saxagliptin and Metformin HCl.