DEVELOPMENT AND VALIDATION OF A NOVEL STABILITY INDICATING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR RELATED SUBSTANCES AND ASSAY ANALYSIS OF MOLNUPIRAVIR DRUG SUBSTANCE AND DRUG PRODUCT.

Molnupiravir, a broad-spectrum antiviral is an isopropyl ester prodrug of ß-D-N4-hydroxycytidine. Molnupiravir targets RNA-dependent RNA-polymerase enzyme of the viruses. A new stability-indicating HPLC-method was developed to determine related substances and assay of molnupiravir. Separation was achieved by using Shim-pack GWS C18 column. The method was validated according to current ICH requirements. The calibration plot gave a linear relationship for all known analytes over the concentration range from LOQ to 200%. LOD and LOQ for all known analytes were found in 0.05-0.08 µg mL-1 and 0.12-0.20 µg mL-1, respectively, the mean recovery was found to be 97.79-102.44 %. Study showed that the method, results of robustness, solution stability studies are precise and within the acceptable limits. Molnupiravir was found to degrade in acid, alkali, and oxidative conditions, and was stable in thermal, moisture, and photolytic degradation condition. The method is simple, accurate, precise, and reproducible for routine purity analysis of drug-samples. [ABSTRACT FROM AUTHOR]