Background: Molnupiravir was granted approval by the UKS medicines and health product regulatory agency on 04 November 2021 and on 23 December 2021, granted emergency use of authorization by FDA. Objective: Provide a technique for measuring Molnupiravir in active pharmaceutical ingredients and formulations. Method: The wavelength maximum was found to be 236 nm. ICH guidelines were followed. The forced degradation study in the form of acidic, alkali, thermal, photolytic, hydrolytic, and oxidative stress conditions was carried out for Molnupiravir. Results: The method was linear, as measured by a coeffi cient of correlation (R2) of 0.9991 in the 10 to 50 μg/mL range. The %RSD for precision, accuracy, limit of detection (LoD), limit of quantitation (LoQ), ruggedness, and robustness was within acceptable limits per ICH Q2 (R1). Conclusion: HPLC equipped with a UV detector is used to create and verify the proposed method. An acetonitrile mobile phase component of 20% was used, demonstrating the more cost-eff ective technique. The extensive data of mobile phase optimization gives a complete idea of fi nal chromatographic conditions, which can be further implemented for future analysis. Molnupiravir shows less than 4% degradation under diff erent stress conditions. The forced degradation data helps show stability, indicating the behavior of Molnupiravir.
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. Method The wavelength maximum was found to be 236 nm. The developed method was validated according to ICH guidelines and found to be linear within range of 10-50µg/ml with correlation coefficient (R2) 0.9989. 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.
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