HPLC-UV method for quantification of favipiravir in pharmaceutical formulations

This paper details the development and validation of a rapid, simple, precise, accurate, and isocratic High-Performance Liquid Chromatography (HPLC) method for the routine quality control of favipiravir in pharmaceutical formulations. Favipiravir, an antiviral drug, was investigated due to its potential as a COVID-19 treatment. The chromatographic separation was achieved using a C18 column with a mobile phase consisting of 50 mM potassium dihydrogen phosphate (pH 2.3) and acetonitrile (90:10, v/v) at a flow rate of 1 mL/min. UV detection was performed at 323 nm, and the column temperature was maintained at 30 °C, resulting in a run time of 15 minutes. The method demonstrated an excellent linear relationship for favipiravir concentrations between 10–100 μg/mL (r² = 0.9999). The sensitivity was confirmed with limits of detection (LOD) and quantification (LOQ) of 1.20 μg/mL and 3.60 μg/mL, respectively. Precision, assessed by interday and intraday relative standard deviation (RSD) for peak area and retention time, was less than 0.4% and 0.2%, respectively. Accuracy was high, with recovery rates between 99.19% and 100.17%. The method was also found to be specific and robust, making it suitable for the quantification of favipiravir in various pharmaceutical preparations.

This paper details the development and validation of a rapid, simple, precise, accurate, and isocratic High-Performance Liquid Chromatography (HPLC) method for the routine quality control of favipiravir in pharmaceutical formulations. Favipiravir, an antiviral drug, was investigated due to its potential as a COVID-19 treatment. The chromatographic separation was achieved using a C18 column with a mobile phase consisting of 50 mM potassium dihydrogen phosphate (pH 2.3) and acetonitrile (90:10, v/v) at a flow rate of 1 mL/min. UV detection was performed at 323 nm, and the column temperature was maintained at 30 °C, resulting in a run time of 15 minutes. The method demonstrated an excellent linear relationship for favipiravir concentrations between 10–100 μg/mL (r² = 0.9999). The sensitivity was confirmed with limits of detection (LOD) and quantification (LOQ) of 1.20 μg/mL and 3.60 μg/mL, respectively. Precision, assessed by interday and intraday relative standard deviation (RSD) for peak area and retention time, was less than 0.4% and 0.2%, respectively. Accuracy was high, with recovery rates between 99.19% and 100.17%. The method was also found to be specific and robust, making it suitable for the quantification of favipiravir in various pharmaceutical preparations. Research Background and Significance Favipiravir, a broad-spectrum antiviral agent originally developed for influenza treatment, gained significant attention during the COVID-19 pandemic due to its potential efficacy against SARS-CoV-2. Accurate quantification of favipiravir in pharmaceutical formulations is critical for quality control, ensuring dosage consistency, efficacy, and patient safety. Analytical methods with high sensitivity, precision, and robustness are essential to support manufacturing and reg