STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF EMPAGLIFLOZIN AND METFORMIN HCl

Abstract

One simple, specific, accurate, precise and reproducible and robust method have been developed and validated for the Simultaneous Estimation of Empagliflozin and Metformin HCl. In Reverse Phase High Performance Liquid Chromatography Method the chromatographic system was equipped with Inertsil ODS-2 (250mm x 4.6 mm, 5µ) as stationary phase and UV detector set at 227 nm, in conjunction with a mobile phase of 0.05M Potassium Dihydrogen Phosphate buffer (pH-3.5, adjusted with 1% Orthophosphoric acid) and Acetonitrile in the ratio of 50:50% v/v at a flow rate of 1.0 ml/min. The described method was linear over a concentration range of 2.5-18.75 μg/ml and 25-75μg/ml for Empagliflozin and Metformin HCl respectively. The retention time of Metformin HCl and Empagliflozin were 2.635 min and 4.388 min respectively. The % recoveries of Empagliflozin and Metformin HCl were found to be 99.60%-100.48% and 100.15%-100.23% respectively. Method was statistically validated for accuracy, precision, specificity, LOD, LOQ and robustness according to ICH guidelines. Developed method was found to be new, accurate, precise and rapid for simultaneous estimation of for Empagliflozin and Metformin HCl.