Abstract

Evogliptin is an anti-diabetic drug, which comes under the class of gliptin derivatives for the inhibition of selective dipeptidyl peptidase-4 inhibitor. The developed ultraviolet spectrophotometric method was simple, sensitive, accurate, precise and economic for the development and validation of evogliptin in bulk and tablet dosage form. In this present study, the analytical method validation and development of evogliptin was done using the different parameters of method validation as per International Council for Harmonisation Q2(R1) guidelines. Water using as a solvent and it shows the maximum wavelength at 266 nm and then performed all the parameters of analytical method validation like accuracy, precision, linearity, range, robustness, ruggedness, limit of detection and limit of quantitation. Evogliptin showed linearity over the range of 2-48 µg/ml. The correlation coefficient value obtained was 0.996 with the regression equation y=0.0032x+0.0005. The accuracy studies was done in spiking method and the recoveries ranging from 97.07 %-106.13 %. The percentage relative standard deviation for intra-day precision was 0.44 and inter-day precision was 0.59. The limit of detection was 1.1 µg/ml and limit of quantitation was 3.33 µg/ml respectively. The method has shown good and consistent recoveries and is validated as per International Council for Harmonisation guidelines and can be used for routine quality control analysis of evogliptin in dosage form.