Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Abstract The current study explores a design and development of the simple, fast, green selective novel method UPLC to quantify pitavastatin ezetimibe simultaneously. combined approach Green Analytical Method with Quality by Design-based risk assessment was done using Ishikawa fishbone diagram followed rotatable central composite used for optimization. optimal chromatographic separation attained through mobile phase 72: 28% v/v ethanol 0.1% orthophosphoric acid (pH 3.5), 0.31 mL min −1 flow rate. developed UPLC-PDA sensitive specific ezetimibe, linearity ranging from 2 30, 10–150 μg an R 0.9999 0.9997, respectively. forced degradation stability-indicating assay results shows in respective stress conditions. validated found have sensible good linearity, accuracy precision. Further, greenness evaluated five states art metrics like NEMI, GAPI, AES, AMGS, AGREE greenest results. Based on we concluded that could be efficient simultaneous determination bulk tablet dosage.