METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF FAVIPIRAVIR BY USING RP-HPLC

Abstract

A robust and precise analytical method was developed and validated through RP – HPLC for the estimation of Favipiravir by using a Discovery 250mm x 4.6 mm, 5m column with Acetonitrile: 0.01N Kh2po4 (70:30 v/v) as mobile phase. The method demonstrated excellent linearity in the concentration ranges of and 10–60 μg/ml for Favipiravir with correlation coefficients (R²) of 0.999 for both drugs, confirming strong linearity. The regression equations obtained were and y = 63434x + 13743 for Favipiravir. The assay results indicated high accuracy with mean assay values of 99.46% for Favipiravir. Specificity studies confirmed the method’s ability to distinctly quantify both analytes without interference. System suitability and method precision showed %RSD values within acceptable limits (≤2%), ensuring reproducibility. Accuracy studies yielded recoveries of 99.54% for Favipiravir. The sensitivity of the method was demonstrated by low limits of detection (LOD) and quantification (LOQ), observed at 0.03 μg/ml and 0.10 μg/ml for Favipiravir, respectively. Robustness studies further confirmed method reliability under small variations in method parameters