Analytical method development and validation for the simultaneous estimation of Darunavir and Ritonavir by RP-HPLC method

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Darunavir and Ritonavir in tablet dosage form. Chromatogram was run through standard symmetry C18 (4.6 x 150 mm, 5m). Mobile phase containing Buffer 0.01N KH2PO4: Acetonitrile taken in the ratio 45:55%v/v was pumped through column at a flow rate of 1ml/min. Optimized wavelength selected was 290 nm. Retention time of Darunavir and Ritonavir were found to be 2.131 min and 2.593 min. %RSD of the Darunavir and Ritonavir were and found to be 0.8 and 0.6 respectively. %Recovery was obtained as 99.59% and 99.94% for Darunavir and Ritonavir respectively. LOD, LOQ values obtained from regression equations of Darunavir and Ritonavir were 0.86, 2.60 and 0.09, 0.29 respectively. Regression equation of Darunavir is y = 12533x + 10387 and y = 9061x + 183.8 of Ritonavir. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.