Method Development and Validation of Stability Indicating RP-HPLC Assay for The Determination of Molnupiravir in Capsules Formulation

The main objective of this study is to validate a specific, simple, robust, and gradient RP-HPLC method for the assay of Molnupiravir in capsule dosage forms. The mixture of 0.1% formic acid: ACN (98:2 v/v) and 100% ACN were used as a mobile phase with gradient elution. A flow rate of 1.0 ml/min was used. An YMC C18 column (150 x 4.6 mm, 3 µm) was selected for chromatographic separation. A 260 nm wavelength was selected for the UV detector and the run was over after 16 minutes. The RT was observed at 8.8 minutes for Molnupiravir. The linear responses were observed for molnupiravir in the range of 20-150 μg/mL with R2 = 0.999. The % RSD values for interday and intraday precision were 1.75 and 0.38 respectively. The results of system suitability such as tailing factor and theoretical plates were found 0.95 and 234265 respectively. The mean percentage recoveries ranged from 98 to 102 (RSD < 2%). The drug remains stable in solution for up to 48 hours. In accordance with ICH requirements, method was validated for all parameters. Overall, a validated RP-HPLC method for the assay of molnupiravir in capsule dosage form was developed and successfully verified.