Application of Quality by Design (QbD) Approach for Development and Validation of an HPTLC Method for Estimation of Molnupiravir in API and Capsule Dosage Form

The primary objective of this research was to estimate a simple, rapid, and reliable HPTLC method using QbD approach for the quantification of Molnupiravir in both its active pharmaceutical ingredient (API) and capsule formulations. As method utilises systematic approach, the study initiated with finding QTTP, ATP, CMA and RA study. A central composite experimental design with response surface methodology was utilized to study the effects of chromatographic chamber saturation time, band length on Rf value of Molnupiravir. The optimized chromatographic conditions were 15 Minute saturation time, 6 mm band length and Toluene: Methanol: ethyl acetate: Formic acid (2:1:7:0.1 v/v/v/v) as a mobile phase. In the present study the design space was identified using design expert software and an optimized method was chosen for validation. The percent assay of marketed formulation was found 100.7%. Therefore, the established method is accurate, precise, and robust, demonstrating its applicability for the routine quality control of API and its formulation.