Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and Pharmaceutical Dosage Form

https://doi.org/10.54037/WJPS.2022.100105

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Sitagliptin and Ertugliflozin in API and Tablet dosage form. Chromatogram was run through Std Ascentis C18 150 x 4.6 mm, 2.7m. Mobile phase containing Buffer 0.01N Ammonium acetate: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 0.9ml/min. Buffer used in this method was 0.01N Ammonium acetate. Temperature was maintained at 30°C. Optimized wavelength selected was 220nm. Retention time of Sitagliptin and Ertugliflozin were found to be 2.151min and 2.722min. %RSD of the Sitagliptin and Ertugliflozin were found to be 1.2 and 0.8 respectively. %Recovery was obtained as 99.99% and 100.61% for Sitagliptin and Ertugliflozin respectively. LOD, LOQ values obtained from regression equations of Sitagliptin and Ertugliflozin were 0.69, 0.05 and 2.10, 0.15 respectively. Regression equation of Sitagliptin is y = 28297x + 20644, and y = 74691x + 2292.1 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.