Development and Validation of RP-HPLC Method for the Quantitative Estimation of Favipiravir in Bulk and Pharmaceutical Dosage Form

Abstract

Favipiravir is an antiviral drug, used in the treatment of SARS-COV-2, novel corona virus. It is a pyrazine carboxamide derivative with activity against RNA viruses A sensitive new RP-HPLC method was developed for the quantitative estimation of Favipiravir in bulk and pharmaceutical dosage form using Rivaroxaban as internal standard (IS). The separation of drug was achieved by Enable C18 column using acetonitrile and water as mobile phase at a ratio of 70:30 %v/v with a flow rate of 1mL/min and wavelength at 296nm respectively. The retention time of Favipiravir and Rivaroxaban were found to be 3.110 and 4.287 mins. The developed method was validated according to ICH Q2 (R1) guidelines over the concentration range of 5-25 µg /mL. The LOD and LOQ were found to be 2.17 µg /mL and 6.58 µg /mL. The method was found to be linear, specific, accurate, precise and robust. The developed method was used for determination of Favipiravir in pharmaceutical dosage forms. Keywords- Favipiravir, Antiviral, Rivaroxaban, ICH guidelines and Validation.