Development and validation of a new stability indicating RP-UFLC method for the quantification of Molnupiravir

Molnupiravir is an anti-viral medication. A new stability indicating RP-UFLC method was proposed for the estimation of Molnupiravir in capsules. Shimadzu Model CBM-20A/20 Alite UFLC system with PDA detector and Zorbox C₁₈ column were used for the chromatographic study. Mobile phase mixture consisting of 0.1% Acetic acid: Acetonitrile (35:65, v/v) with a flow rate 0.8 ml/min was chosen for the chromatographic elution of Molnupiravir (Detection wavelength 245 nm). The method was linear over the concentration range 2.0-100 µg/ml with linear regression equation, y = 29137x + 3455.8 (R² = 0.9999). The LOD and LOQ were found to be 0.4574 µg/ml and 1.548 µg/ml respectively. Forced degradation studies were performed and the method was validated as per ICH guidelines.