Development and Validation of Stability Indicating RP-HPLC Assay and Related Substances Method For The Quantitative Determination of Favipiravir In Solid Dosage Form

Abstract

A simple, sensitive, and reproducible reversed-phase high-performance liquid chromatography (RP-HPLC) method, coupled with a photodiode array detector, was developed for the determination of Favipiravir (FVP) and its related substances in solid dosage form. Chromatographic separation was achieved on the Inertsil ODS 3V (250 mm x 4.6 mm, 5 μm) column for assay and Inertsil ODS 4 (250 mm x 4.6 mm, 3 μm) for Related substances with a mobile phase containing a gradient mixture of a Mobile phase A (0.02M Ortho Phosphoric Acid) and Mobile phase B [MPA: Acetonitrile (30: 70)]. The eluted compounds were monitored at 323 nm and 210 nm for the assay & related substances test respectively, the flow rate was 1.0 mL/min and 0.7 mL/min respectively for the assay and related substances test and the column oven temperature was maintained at 25°C for assay and related substances test. The runtime was 21 minutes and 60 minutes for the assay and related substances test respectively. Favipiravir drug product was subjected to the stress conditions of oxidative, acid, alkali, humidity, thermal and photolytic degradation. Favipiravir was found to degrade significantly under acid (6.1%) and alkali (15.2%) stress conditions and degrade slightly under oxidative, thermal, humidity and photolytic stress conditions. All impurities were well-resolved from the main peak, showing the stabilityindicating power of the method. The developed method was validated as per the International Conference on Harmonization (ICH Q2 R1) guidelines.