Stability-Indicating HPLC method for estimation of omarigliptin in tablets – Oxidative and photolytic kinetics and degradation products formed under oxidative conditions

Abstract

After the development and validation of a stability indicating analytical method for omarigliptin (OMG) using the HPLC method, a study of oxidative and photolytic degradation kinetics and identification of the main degradation products obtained after stress testing under oxidative conditions of this substance and the degradation pathway, was proposed. The separations were performed using an Agilent ZORBAX C8 250 × 4.6 mm column and the mobile phase consisted of 10 µM phosphate buffer and methanol 45:55 (v/v) with 230 nm wavelength detection. The HPLC method was validated according to official guides. It showed to be sensitive, accurate, precise, linear, robust and specific and was successfully used to determine the drug in its pharmaceutical formulation, to investigate the degradation kinetics of omarigliptin in the oxidative and photolytic medium and to get to know the reaction rate. Mass spectrometry was useful to identify the main oxidative degradation products and chemical analysis was used as a proposal to estimate the degradation routes of OMG.