An Antiviral drugs gained more importance due to SARS-COV-2 infection and many drugs are under investigation in order to end pandemic. Molnupiravir is an investigational medicinal product being developed by Merck Sharp and dohme in collaboration with Ridgeback for treatment of COVID-19. Molnupiravir is the 5l – isobutyrate prodrug of the antiviral ribonucleoside analogue N-hydroxycytidine (NHC). Molnupiravir inhibits viral preproduction by promoting widespread mutations in the replication of viral RNA by RNA-directed RNA polymerase. In this study a simple, economical Reverse phase high performance Liquid Chromatographic (HPLC) method was developed and validated for estimation of Molnupiravir in bulk and pharmaceutical dosage form. The wavelength maximum was found to be 236nm. The developed method was validated according to ICH guidelines and found to be linear within range of 10-50µg/ml with correlation coefficient (R2) 0.9991. The %RSD for precision, accuracy, LOD, LOQ, Ruggedness, Robustness were within range of acceptable limit as per ICH Q2 (R1). Molnupiravir was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions.
An Antiviral drugs gained more importance due to SARS-COV-2 infection and many drugs are under investigation in order to end pandemic. Molnupiravir is an investigational medicinal product being developed by Merck Sharp and dohme in collaboration with Ridgeback for treatment of COVID-19. Molnupiravir is the 5l – isobutyrate prodrug of the antiviral ribonucleoside analogue N-hydroxycytidine (NHC). Molnupiravir inhibits viral preproduction by promoting widespread mutations in the replication of viral RNA by RNA-directed RNA polymerase. In this study a simple, economical Reverse phase high performance Liquid Chromatographic (HPLC) method was developed and validated for estimation of Molnupiravir in bulk and pharmaceutical dosage form. The wavelength maximum was found to be 236nm. The developed method was validated according to ICH guidelines and found to be linear within range of 10-50µg/ml with correlation coefficient (R2) 0.9991. The %RSD for precision, accuracy, LOD, LOQ, Ruggedness, Robustness were within range of acceptable limit as per ICH Q2 (R1). Molnupiravir was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions.