New analytical method development and validation for estimation of molnupiravir in bulk and tablet dosage form by RP-HPLC method

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 C۱۸ (۴.۶×۱۵۰mm, ۵µm) column. The mobile phase used contained Methanol. Phosphate Buffer pH-۴.۲ adjusted with Orthophosphoric acid solution in the ratio of ۳۵:۶۵% v/v in an isocratic mode at a wavelength of ۲۳۶nm. The mobile-phase flow rate and the sample volume injected were ۱ ml/min and ۱۰ μL, respectively. The retention time of Molnupiravir was found to be ۲.۸ ±۰.۲mins. A good linear relationship of Molnupiravir r =۰.۹۹۹) was observed over a concentration range of ۲۰ to ۱۰۰µg/ml of Molnupiravir. The limit of detection (LOD) and limit of quantification (LOQ) for Molnupiravir was found to be ۲.۶µg/ml and ۶.۳۵µg/ml. The recovery percentage was observed in the range of ۹۸-۱۰۲%. The relative standard deviation for the precision study was found <۲%. 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.

Keywords:

Precision , PDA Detection , ICH guidelines , robustness , Covid -۱۹ , SARS-CoV-۲