QbD BASED UV AND RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF VILDAGLIPTIN IN BULK API

Abstract

Abstract The present study aimed to develop and validate UV-Visible spectrophotometric and QbD-based RP-HPLC analytical methods for the quantitative estimation of Vildagliptin in bulk drug. UV spectrophotometric analysis was performed using Methanol:Water (60:40 v/v) as solventand detection at 244 nm. The RP-HPLC method was developed using a C18 column withPhosphate Buffer:Acetonitrile as the mobile phase and optimized through a Box–BehnkenDesign under Analytical Quality by Design (AQbD) principles. Both methods were validatedaccording to ICH Q2(R1) guidelines for linearity, accuracy, precision, limit of detection, limitof quantitation, and robustness. The UV method exhibited excellent linearity (R2 = 0.9992),while the RP-HPLC method showed superior linearity (R2 = 0.9991) and enhanced sensitivitywith lower LOD and LOQ values. The developed methods demonstrated acceptable accuracy,precision, and reproducibility. The AQbD-based RP-HPLC method was found to be robust,reliable, and suitable for routine quality control analysis of Vildagliptin.