RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF ERTUGLIFLOZIN AND METFORMIN IN PHARMACEUTICAL DOSAGE FORMS

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Metformin and
Ertugliflozin in Tablet dosage form. Chromatogram was run through Std BDS C18 150 x 4.6 mm, 5. Mobile
phase containing Buffer 0.1% OPA (3.0ph): Acetonitrile taken in the ratio 55:45 was pumped through column at
a flow rate of 1 ml/min. Buffer used in this method was 0.1% OPA. Temperature was maintained at 30°C.
Optimized wavelength selected was 230 nm. Retention time of Metformin and Ertugliflozin were found to be
2.565min and 3.221min. %RSD of the Metformin and Ertugliflozin were and found to be 0.1 and 0.5
respectively. %Recovery was obtained as 100.52% and 99.80% for Metformin and Ertugliflozin respectively.
LOD, LOQ values obtained from regression equations of Metformin and Ertugliflozin were 0.36, 1.08 and 0.01,
0.03 respectively. Regression equation of Metformin is y = 21782x + 8044.9., and y = 18601x + 127.71 of
Ertugliflozin . Retention times were decreased, and that run time was decreased, so the method developed was
simple and economical that can be adopted in regular Quality control test in Industries.