Novel stress indicating RP-HPLC method development and validation for the simultaneous estimation of ertugliflozin and sitagliptin in bulk and its formulation

Abstract

A selective, sensitive RP-HPLC method was developed for the simultaneous estimation of the Ertugliflozin (ETR) and Sitagliptin (SGT) in bulk and its dosage form. The separation and determination was carried on water's C18 column capacitate (250X4.6 mm, 5 μm particle size), retention times of Ertugliflozin and Sitagliptin were found to be 2.39 and 4.60 min. respectively. The wavelength was fixed at 215 nm with PDA detection. The mobile phase was consisted mixture of 0.5 mM potassium dihydrogen ortho phosphate buffer: Methanol in the ratio of 55:45 v/v, pH 5.3 was adjusted with HCl and flow of mobile phase was maintained 1mL/min. The calibration curve was linear and regression co-efficient (R2) value found to be 0.999 and concentration ranging from 37.5-112.5 and 250-750 μg/mL for Ertugliflozin and Sitagliptin respectively. The quantization limit and detection limit of the method were found 0.1 & 0.3 μg/ml and 0.4 and 1μg/ml for Ertugliflozin and Sitagliptin.