New UV Spectrophotometric Method for the Estimation of Molnupiravir used in the treatment of COVID-19

Abstract

Background: Antiviral drugs gained more importance due to SARS-COV-2 infection and many drugs are under investigation to end the pandemic. Molnupiravir is an investigational medicinal product being developed by Merck Sharp and Dohme in collaboration with Ridgeback for the treatment of COVID-19. Objective: A new, simple, and economical UV-spectrometric method was developed and validated for the estimation of Molnupiravir in a bulk and pharmaceutical dosage form. Methods: The maximum wavelength was found to be 236 nm. The developed method was validated according to ICH guidelines and found to be linear within the range of 10-50µg/ml with a correlation coefficient (R2) 0.9989. Results: The %RSD for precision, accuracy, LOD, LOQ, Ruggedness, and Robustness were within the range of acceptable limits as per ICH Q2 (R1). The accuracy of the method was determined at three concentration levels and found to be 99.87%, 99.53%, and 99.84%. Conclusion: All parameters obtained are within acceptable limits as per ICH guidelines. The molnupiravir was exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions and its stability data was determined which will be useful for further formulation development.