Comprehensive Method Development and Validation of RP-HPLC for Molnupiravir Quantification in Medicinal Dosage Forms

Abstract Molnupiravir has been granted emergency use authorization status by the European Medicines Agency (EMA) to treat mild-to-moderate COVID-19 in adults who have tested positive for the virus via direct SARS-CoV-2 viral testing. The aim of this research endeavor was to develop and validate a RP-HPLC (Reverse Phase High-Performance Liquid Chromatography) technique that could accurately measure the concentration of molnupiravir in pharmaceutical dosage forms. The study centered on the careful refinement of chromatographic parameters, employing a Thermo Fisher Scientific HS-C18 column as the immobile phase. The solvent system, which be made up of a solution containing H2O: ACN (70:30 % V/V), was carefully preferred