Development and validation of a new stability indicating RP-UPLC method for the simultaneous estimation of Nirmatrelvir and Ritonavir in presence of internal standard (Velpatasvir)

Abstract

A new stability indicating RP-UPLC method has been proposed for the simultaneous

estimation of Nirmatrelvir and Ritonavir in presence of an internal standard, Velpatasvir using

Waters ACQUITY UPLC system with PDA detector and Hibar C18 (100 x 2.1 mm, 1.8)

column. Mobile phase consisting of 0.01M Ammonium acetate and Acetonitrile (60:40, v/v)

was used with flow rate 0.3 ml/min (Detection wavelength: 260 nm) (Injection volume: 1.0

L) (Column temperature: 30°C) with run time 6 mins. The method was linear over the

concentration range 30-180 µg/ml and 10-60 µg/ml for Nirmatrelvir and Ritonavir respectively.

Forced degradation studies were performed and the method was validated as per ICH

guidelines.