STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND GLIPIZIDE

Abstract

A novel, precise and accurate stability indicating RP-HPLC method was developed and validated for the simultaneous estimation of Metformin and Glipizide in combined pharmaceutical dosage form. Chromatographic separation was achieved on Microsorb-MV C18 column (250 × 4.6 mm, 5 μm) with UV detection at 257 nm. The mobile phase consists of acetate buffer (pH 4.0) and acetonitrile in the ratio of 60:40 v/v and at a flow rate of 1.0 mL/min. The method was linear over the concentration range of 60-140 μg/mL for Metformin and 10-50 μg/mL for Glipizide. The retention times for Metformin and Glipizide were found to be 2.434 min and 5.710 min respectively. The mean percentage recoveries of Metformin and Glipizide were found to be 100.42% and 100.39% respectively. The method was validated and was successfully employed for the routine quantitative analysis of pharmaceutical formulations containing Metformin and Glipizide in combined pharmaceutical formulation.