Abstract

STABILITY INDICATING CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HCl & ANAGLIPTIN IN ITS SYNTHETIC MIXTURE BY HPLC

Purva B. Bhatti* and Dr. Hiral J. Panchal

Abstract

A simple, rapid and accurate stability indicating RP-HPLC method was developed for the simultaneous estimation of Metformin HCl & Anagliptin in its synthetic mixture. The method showed a linear response for concentration of range of 5-15μg/ml using Potassium Phosphate Buffer(PH 7): Acetonitrile solution in the ratio of (35:65) as the mobile phase with detection at 240 nm and flow rate 1ml/min and the retention time for Metformin HCl and Anagliptin was found to be 4.227 and 5.893 respectively. The method was validated for the Specificity, Precision, Robustness, Accuracy, LOD, LOQ, Assay. The drug undergoes degradation under Acidic, Basic, Oxidation, Photolytic and Thermal degradation. All the peaks of degraded product were resolved from active ingredient with significantly different retention time. This method can be employed as a stability indicating one.

Keywords: Metformin HCl, Anagliptin, RP-HPLC, Degradation Studies.