Method Development and Validation for the Quantification of Molnupiravir by RP HPLC in Capsule Dosage form

Abstract

The aim of this study was to devise an RP-HPLC method that is straightforward, accurate, and economical for determining Molnupiravir levels in pharmaceutical formulations. The chromatographic analysis was conducted using Kromasil C18 column (150 mm x 4.6 mm, 3µ) with a mobile phase consisting of a Buffer solution (Phosphate buffer pH 4) and methanol in a 55:45 % v/v ratio. The flow rate was maintained at 1.0 ml/min, with an injection volume of 10 µL and a total run time of 10 minutes. Detection was performed at a wavelength of 272 nm. The detector exhibited a linear response within the concentration range of 40 – 300 µg/ml, with a correlation coefficient of 1.000. Validation of this analytical method was carried out following ICH guidelines. The developed method has been successfully employed for the estimation of Molnupiravir in pharmaceutical formulations.