Development of stability indicating liquid chromatographic method for estimation of novel anti‐diabetic drug Evogliptin

Abstract

Abstract Evogliptin (EVG) is prescribed in the treatment of type 2 diabetes. An accurate and precise high‐performance liquid chromatographic method along with forced degradation studies and design of experiments has been developed for the estimation of EVG. Agilent C 18 Column (250 × 4.6 mm, 5 μm particle size) was used as the stationary phase and methanol: 0.05% Orthophosphoric acid in water (51: 49% V/V) was used as the mobile phase. The method was linear in the concentration range of 5–30 μg/ml with a correlation coefficient (r 2 ) of 0.9996. The proposed method was validated with respect to linearity, accuracy, precision, and robustness as per the International Conference on Harmonization Q2 (R1) guideline. A forced degradation study was performed to find out the intrinsic stability of the molecules. The degradation products were well resolved from the drug peak and did not interfere with the analysis. The method was successfully applied for the analysis of EVG.