Development of a Simple Accurate Method, Validation and It’s Degradation Studies of Nirmatrelvir, Ritonavir in Bulk and Marketed Formulation by RP-HPLC

Abstract

An easy, accurate, and precise method used for simultaneous quantification of nirmatrelvir, ritonavir in bulk and marketed formulation by reverse phase high performance liquid chromatography (RP-HPLC) using a standard column Inertsil ODS (150 x 4.6 mm, 5 μm ) at a rate of flow 1-mL/min, acetonitrile and buffer containing hexane sulphonic acid, 50:50 v/v as a mobile phase was introduced through the HPLC column, detected at a wavelength 258 nm. Nirmatrelvir and ritonavir retention times were 2.481 and, 3.873 minutes, respectively. %Recovery rates for nirmatrelvir and ritonavir were 100 and 100.3%, respectively. LoD and LoQ values for nirmatrelvir and ritonavir were 1.5, 1 and 4.5, 3 g/mL, respectively. Nirmatrelvir regression equation is y = 32885.25x + 4223.04 while ritonavir is y = 39086.65x + 1680.21. Stability indicating studies done by acid, alkali, peroxide, Reduction, thermal, neutral and ultra violet light. The newly created reverse phase HPLC method, for bulk and marketed formulation, was rapid, stability indicating and accurate