STABILITY INDICATING METHOD DEVELOPMENT AND METHOD VALIDATION FOR THE ESTIMATION OF FAVIPIRAVIR IN BULK AND PHARMACEUTICAL DOSAGE PREPARATIONS BY RP-UPLC

A Precise, Specific, Accurate, Robust and Rugged stability indicating RP-UPLC method has been developed and validated for the estimation of Favipiravir in bulk and pharmaceutical dosage form (Tablets) was carried out by UPLC Instrument with Waters Acquity C18 (100mmx2.7mm ID) 1.7μm column as stationary phase by using mobile phase in Isocratic mode with a mixture of 20mM Phosphate Buffer of pH 2.5: Acetonitrile: Methanol (50:30:20 v/v/v)at a flow rate of 0.5mL/min and detection was carried out at 254nm. The Retention time of Favipiravir was 1.62 min. System precision results obtained within the acceptance criteria i.e., %RSD < 2.0. Correlation coefficient value obtained to be more than 0.999 and % Recovery for Favipiravir was obtained in between 98.0 to 102.0 in this method. In method precision, mean %Assay obtained between 95.0 to 105.0%. In forced degradation study, main analyte peak purity was passed; degradation also obtained in the range of 5-30%. Hence method is concluded as stability indicating.