STABILITY INDICATING METHOD DEVELOPMENT AND METHOD VALIDATION FOR THE ESTIMATION OF MOLNUPIRAVIR IN BULK AND PHARMACEUTICAL DOSAGE PREPARATIONS BY RP-UPLC

Stability indicating UPLC method has been developed for the estimation of Molnupiravir in bulk and capsule dosage form. Estimation of Molnupiravir by this method is rapid and reliable. This RP-UPLC method was developed and validated by Acquity C18 BEH (100mm x 2.1mm,)1.7μm particle size in isocratic mode, and the sample was analyzed using a ratio of Acetonitrile and 10mM Phosphate Buffer with pH 3.5 (25:75% v/v) as mobile phase at a flow rate of 0.5 ml/min and detection was carried out at 237 nm. Molnupiravir was eluted at the retention time of 1.9min with good efficiency and less tailing (<1.5).  The capsule assay method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH Validation guidelines. Method has shown Precise, Specific, Linear sensitive Accurate, Robust and Rugged results. For Linearity Parameter, Calibration plots in the concentration range of 50-150μg/ml for Molnupiravir and shown correlation coefficient >0.999, and recoveries from capsule dosage form were between 98.0 and 102.0 %. The % assay in Method Precision was shown to be 99.3%. This method can be used for routine of the quality control in pharmaceuticals. The RP-UPLC method was found to be simple, economical and rapid as compared to previous methods. Previous methods were not focused on Forced degradation studies. Those methods may not be used to analyze the stability samples. This method is simple and reliable and as we have performed forced degradation studies, this method is also stability indicating.

Key words: UPLC, Molnupiravir, Waters Acquity BEH C18, Method validation, Forced degradation studies.