HPLC-BASED METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF NIRMATRELVIR AND RITONAVIR IN COMBINATION THERAPY

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Nirmatrelvir and Ritonavir in pharmaceutical dosage form. Chromatogram was run through Kromasil C18 250 x 4.6 mm, 5. Mobile phase containing Buffer 0.1% OPA : Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1.0ml/min. Buffer used in this method was 0.1% OPA. Temperature was maintained at 30°C. Optimized wavelength selected was 240 nm. Nirmatrelvir and Ritonavir were eluted at 2.303 min and 2.783 min respectively. %RSD of the Nirmatrelvir and Ritonavir were and found to be 0.8 and 0.5 respectively. %Recovery was obtained as 99.63% and 99.70% for Nirmatrelvir and Ritonavir respectively. LOD, LOQ values obtained from regression equations of Nirmatrelvir and Ritonavir were 0.04, 0.13 and 0.01, 0.02 respectively. Regression equation of Nirmatrelvir is y = 92901x + 3504.3, and y = 116867x + 4632.7 of Ritonavir.