Stability Indicating HPTLC Method Development and Validation for Quantification of Favipiravir in Bulk and Commercial Film Coated Tablet

Introduction: Favipiravir was remerging antiviral drug in the beginning era of COVID-19 Pandemic as an urgent therapeutic alternative to treat COVID-19. Literature survey reveals that there is no any reported stability indicating HPTLC method for this non-pharmacopoeial drug. So current scheme of research work focuses on development and Validation of SI-HPTLC method for quantification of FVP in bulk and commercial film coated tablet. Materials and Methods: Silica Gel 60 F254 plates used as stationary phase to carried out chromatographic separation using mobile phase Toluene: Methanol: Ethyl Acetate: Formic acid (7: 1: 2: 0.5). Densitometric scanning of well resolved bands of FVP was carried out at 325 nm. The propose SI-HPTLC method was validated as per ICH Q (R1) guidelines. Results: It was found to be Sensitive, Selective, Accurate and Precise in nature and can be applied for routine In-Process Quality Control testing of Commercial Film Coated Tablet of FVP. FVP was subjected to various stress condition in force degradation study and was found to be more susceptible for alkaline degradation. Alkaline degradants further subjected to LCMS analysis in order to reveal possible degradation pathway of FVP in alkaline condition. Conclusion: Developed HPTLC method is sensitive, accurate, selective and precise in nature and can be applied for quantification for Favipiravir in bulk and commercial film coated tablet.