Development And Validation of a Robust HPTLC Assay Method to Assess the Stability of Molnupiravir Under Various Stress Conditions

Abstract

This research focuses on designing and validating a precise, sensitive, a stability-indicating HPTLC test technique for quantification of molnupiravir medicament formulation. Validation process adhered to the ICH guidelines. Developed High-Performance Thin-Layer Chromatography technique employed Silica Gel G60F254 as stationary phase for effective separation and analysis. The optimized mobile phase consisted of ethanol, ethyl acetate, and formic acid in a 3:6.5:0.5(v/v/v) ratio. Molnupiravir exhibited an Rf value of 0.76 ± 0.01, with a maximum absorbance at 282 nm for detailed analysis. The method exhibited strong linearity with an R² value of 0.9937 over range of concentration 100-300 ng/spot and was thoroughly authenticated for parameters including accuracy, precision, specificity, robustness and linearity. Research was carried out in many circumstances, such as acidic, alkaline, neutral, oxidative, thermal, and photolytic environments. with % of degradation calculated. Significant Degradation was noted. under oxidative and thermal condition. No degradation occurred observed under acidic conditions. The method proved to be selective and reproducible for molnupiravir in both bulk and capsule formulations. The developed method effectively separated drug degradants from the non-degraded drug, confirming its status as a stability-indicating assay method.