New Analytical Method Development and Validation of Molnupiravir in Bulk and Formulation

A straightforward, sensitive, exact, and approved RP-HPLC a methodology has been developed to analyse Molnupiravir API and for its stability-indicating assay. Molnupiravir exhibits its greatest absorbance at 236nm when measured with a UV/Visible detector. The solvent solution and wavelength were modified to maximize the sensitivity of the proposed method. Using a C18 column that measures 250mm, 4.6mm, and 5m, an HPLC system from Waters 2489 uses acetonitrile and water in a 60:40 ratio. The resilience, linearity, specificity, robustness, and precision of the approach were all validated. For the concentration range of 1–32ug/ml, a mean correlation coefficient of 0.9997 was found, indicating linearity. The suggested method recovered MOL between 99.77% and 100.26%. 1.15μg Ml − 1 and 3.50μg mL−1 were the limits of detection (LOD) and quantification (LOQ), respectively. It was proved that the new RP-HPLC process was precise, accurate, and stable indicating. It is useful in the manufacturing of medications containing APIs. When the strategy was validated using the ICH recommendations and the methodologies given, there were no noticeable differences.