Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF NIRMATRELVIR AND RITONAVIR IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Arun Prakash Sisubalan*, Chitra Manickam, Vijayamirtharaj Ramaswamy, Senthilkumar Natesan

.

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Nirmatrelvir and Ritonavir in Tablet dosage form. The developed method was validated as per of ICH guidelines. The chromatographic separation was achieved isocratically on through WATERS- C18, 250 x 4.6 mm, 5μm. Mobile phase containing NaH2PO4: Methanol taken in the ratio 50:50 at 5.1 pH of buffer was pumped through column at a flow rate of 1.0 mL/min. Temperature was maintained at 25°C. Optimized wavelength selected was 235 nm. The separation of Nirmatrelvir and Ritonavir was done at a Retention time of 4.061 and 5.817 minutes respectively. %RSD of the Nirmatrelvir and Ritonavir were found to be 0.21 and 0.22 respectively. Accuracy of method was carried out at three level (50%, 100% and 150 %). %Recovery was obtained as 100.0% and 100.0% for Nirmatrelvir and Ritonavir respectively. LOD, LOQ values obtained from regression equations of Nirmatrelvir and Ritonavir were 0.382, 1.273 and 0.212, 0.707 respectively. Regression equation of Nirmatrelvir is y = 18696x - 90967, y = 27620x -169949 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.

Keywords: Nirmatrelvir, Ritonavir, Antiretroviral drug, UV, HPLC, and Method Development and Validation.