Development and Validation of Stability Indicating High Performance Liquid Chromatography Method for Determination of Molnupiravir in Capsule Dosage Form

Abstract

A simple, rapid and novel reverse phase-high performance liquid chromatography method was developed for quantification of molnupiravir in its capsule dosage form which is recently approved for phase III clinical trials in moderate coronavirus disease patients in India. The chromatographic separation of Molnupiravir was achieved on reverse phase-high performance liquid chromatography using Eclipse Plus C18 (150×4.6 mm, 5 µ) column with buffer (pH 4.5) and methanol (70:30 v/v) as mobile phase. Method was validated in accordance with recommendations of International Council for Harmonisation Q2 (R1) guidelines. The linearity of the method was found to be excellent over the concentration range of 49.80-149.40 µg/ml. The mean of the coefficient of determinations (r2, n=3) was found to be 0.9999. The precision values (percentage relative standard deviation) and overall percentage recovery was found to be acceptable. The proposed method effectively separated the drug from its degradation products. Hence, it can be used as a stability-indicating assay method for the routine analysis of molnupiravir in pharmaceutical formulations.