HPLC-UV method for quantification of favipiravir in pharmaceutical formulations

This study presents the development and validation of a novel, isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of favipiravir, an antiviral drug with potential applications for COVID-19, in pharmaceutical formulations. The method utilizes a C18 column with a mobile phase composed of 50 mM potassium dihydrogen phosphate (pH 2.3) and acetonitrile (90:10, v/v) at a flow rate of 1 mL/min. Detection was performed using a UV detector at 323 nm, and the column temperature was maintained at 30 °C. The total run time for the analysis was 15 minutes. The method demonstrated excellent linearity over a concentration range of 10–100 μg/mL, with a correlation coefficient (r²) of 0.9999. The validation of the method was performed according to ICH guidelines and showed high sensitivity, with a limit of detection (LOD) of 1.20 μg/mL and a limit of quantification (LOQ) of 3.60 μg/mL. The method also proved to be precise, with intraday and interday relative standard deviations (RSD) for peak area and retention time below 0.4% and 0.2%, respectively. Furthermore, the method was found to be accurate, with recovery values ranging from 99.19% to 100.17%. The robustness of the method was confirmed by the low RSD values (<1.00%) for system suitability parameters. The developed method was successfully applied to the quantification of favipiravir in commercially available pharmaceutical formulations, demonstrating its suitability for routine quality control analysis.

This study presents the development and validation of a novel, isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of favipiravir, an antiviral drug with potential applications for COVID-19, in pharmaceutical formulations. The method utilizes a C18 column with a mobile phase composed of 50 mM potassium dihydrogen phosphate (pH 2.3) and acetonitrile (90:10, v/v) at a flow rate of 1 mL/min. Detection was performed using a UV detector at 323 nm, and the column temperature was maintained at 30 °C. The total run time for the analysis was 15 minutes. The method demonstrated excellent linearity over a concentration range of 10–100 μg/mL, with a correlation coefficient (r²) of 0.9999. The validation of the method was performed according to ICH guidelines and showed high sensitivity, with a limit of detection (LOD) of 1.20 μg/mL and a limit of quantification (LOQ) of 3.60 μg/mL. The method also proved to be precise, with intraday and interday relative standard deviations (RSD) for peak area and retention time below 0.4% and 0.2%, respectively. Furthermore, the method was found to be accurate, with recovery values ranging from 99.19% to 100.17%. The robustness of the method was confirmed by the low RSD values (<1.00%) for system suitability parameters. The developed method was successfully applied to the quantification of favipiravir in commercially available pharmaceutical formulations, demonstrating its suitability for routine quality control analysis. Research Background and Significance Favipiravir, a purine nucleic acid analog, has gained significant attention as an antiviral agent, particularly due to its potential application in treating viral infections such as COVID-19. Accurate and reliable quantification of favipiravi