A validated stability indicating RP-HPLC method for the determination of molnupiravir in pharmaceutical dosage form

Abstract

A simple, Precise, Accurate method was developed for the estimation of Molnupiravirby RP-HPLC technique. Chromatographic conditions used are stationary phase Agilent C18 (250 mm*4.6mm3.6m), Mobile phase Orthophopoaricacid: Acetonitrile in the ratio of 60:40 and flow rate was maintained at 1.0 mL/min, detection wave length was 254 nm, column temperature was set to 30o C and diluent was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. The retention time for Molnupiravir was 2.46 min. The method was validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. Limit of detection and limit of quantification were found 0.06 μg/ml and 0.21 μg/ml respectively and recovery of Molnupiravir from tablet formulation was found 99.73%. The proposed method was successfully applied for the quantitative determination of Molnupiravir in tablet formulation.