Spectrophotometric Method Development and Validation for the Determination of Molnupiravir in Bulk Powder and Pharmaceutical Formulation.

Document Type : Original Article

Authors

1 Chemistry Department, Faculty of Science, Ain Shams University, Abbassia, Cairo, 11566, Egypt.

2 Chemistry Department, Faculty of Science, Ain Shams University, Abbassia, Cairo, Egypt

Abstract

A simple fast ecofriendly spectrophotometric method was developed and applied successfully for accurate and sensitive assessment of Molnupiravir (MOL) in pure bulk powder and pharmaceutical formulation. The solvent used during measurements was a mixture of ethanol and water in ratio (1:1, v/v) where the λmax of MOL was observed at 230.0 nm. Linearity for MOL was displayed within the concentration range of 2.5-20.0 μg/mL exhibiting 0.9997 as the correlation coefficient. The method validation was performed in accordance to ICH guidelines while the limits of detection and quantification were calculated and found to be 0.37 and 1.11 μg/mL; respectively. The obtained results assured method specificity where MOL can be determined in the presence of common pharmaceutical excipients.

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