ABSTRACT

Favipiravir (6-fluoro-3-hydroxy-2-pyrazine carboxamide) is an antiviral drug that specifically and potently inhibits the RNA-dependent RNA polymerase enzyme of RNA viruses. A straightforward stabilityindicating high-performance liquid chromatography (RP-HPLC) approach can be used to identify favipiravir, its known contaminants, and degradation products. This approach is exact, accurate, and repeatable. The process was validated according to the current International Council for Harmonization requirements. Within the acceptance criteria, the suggested technique exhibits outstanding accuracy, linearity, precision, robustness, specificity, LOD, LOQ, and system applicability findings. For all known analytes over the concentration range from LOQ to 200% of the specification level, the calibration plot revealed a linear relationship. LOD and LOQ were found in the field to be 0.02-0.16 μg mL-1 and 0.06-0.40 μg mL-1 for all known analytes, respectively. A recovery study was used to determine the suggested method’s accuracy. Studies on solution stability and robustness produced results that fell within acceptable bounds . The devised technique is appropriate for routine analysis.