Abstract
A new simple, selective, rapid, precise reversed-phase high-performance liquid chromatography method has been developed and validated for the estimation of Molnupiravir in bulk and its pharmaceutical dosage form. The separation was made using Symmetry ODS C18 (4.6×150mm, 5µm) column. The mobile phase used contained Methanol. Phosphate Buffer pH-4.2 adjusted with Orthophosphoric acid solution in the ratio of 35:65% v/v in an isocratic mode at a wavelength of 236nm. The mobile-phase flow rate and the sample volume injected were 1 ml/min and 10 μL, respectively. The retention time of Molnupiravir was found to be 2.8 ±0.2mins. A good linear relationship of Molnupiravir r =0.999) was observed over a concentration range of 20 to 100µg/ml of Molnupiravir. The limit of detection (LOD) and limit of quantification (LOQ) for Molnupiravir was found to be 2.6µg/ml and 6.35µg/ml. The recovery percentage was observed in the range of 98-102%. The relative standard deviation for the precision study was found <2%. The developed method is simple, precise, specific, accurate and rapid, making it suitable for the estimation of Molnupiravir in bulk and marketed pharmaceutical dosage form. It was concluded that in the present developed RP- HPLC method is simple, rapid, and accurate, hence can be used for routine quality control analysis in the Pharmaceutical industry.
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