Development and validation of RP-HPLC method for simultaneous estimation of Ertugliflozin and Sitagliptin in bulk drug and tablet dosage form

Abstract

To treat type 2 diabetes, in a combined tablet dosage form the ertugliflozin and sitagliptin were administered. Considering the less complication and readily availability of HPLC, the main objective of present study was to develop a new, precise, accurate, linear, robust, and economical RP-HPLC method for the simultaneous estimation of ertugliflozin and sitagliptin in tablet dosage form. Effective chromatographic separation of Ertugliflozin and Sitagliptin was achieved on Kromasil C18 (5 µm 250 mm X 4.6 mm) and the mobile phase containing Methanol and 0.1% OPA in water isocratic elution mode at a flow rate of 1.0mL/min. with column temperature at 30 °C and the injection volume was 20 µL at column temperature at 30°C. At an isosbestic wavelength of 212 nm, ertugliflozin and sitagliptin were found to have retention times of 5.30 min. and 2.05 min., respectively. The method was proven to be precise (%RSD 2%), accurate (>90%), and specific for the simultaneous measurement of both drugs in tablets. As a result, the suggested method with excellent specificity, accuracy, precision, linearity and robustness as well as economical was useful for the regular quality control analysis of ertugliflozin and sitagliptin tablets.