Validated RP-HPLC Method Development for Estimation of Ertugliflozin and Sitagliptin in Bulk and Dosage Forms

Abstract

A simple, accurate, precise method was developed for the simultaneous estimation of the Ertugliflozin and Sitagliptin in bulk and tablet dosage form. Chromatogram was run through Std Discovery C18150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% OPA (2.2ph): Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.1% Ortho Phosphoric Acid (OPA). Temperature was maintained at 30°C. Optimized wavelength selected was 218 nm. Retention time of Ertugliflozin and Sitagliptin were found to be 2.228min and 2.880min. %RSD of the Ertugliflozin and Sitagliptin were and found to be 0.4 and 0.7 respectively. %Recovery was obtained as 99.23% and 100.01% for Ertugliflozin and Sitagliptin respectively. LOD, LOQ values obtained from regression equations of Ertugliflozin and Sitagliptin were 0.20, 0.61 and 0.46, 1.40 respectively. Regression equation of Ertugliflozin is y = 43997x + 2639, and y = 46501.x + 13112 of Sitagliptin. 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.