ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FAVIPIRAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

There is a need for developing and validating a precise, accurate, and robust Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method that would be able to accurately determine the amount of Favipiravir contained in a particular formulation of pharmaceuticals. An optimized ratio of buffered organic solvent and a suitable C18 column were used in combination with a mobile phase composed of a suitable buffer and organic solvent. To perform a selective analysis, UV detection at a pre-determined wavelength was employed to perform the detection. ICH Q2(R1) guidelines were followed in the validation of the developed method, and it was evaluated for key parameters, including specificity, linearity, accuracy, precision (intra-day and inter-day), limit of detection (LOD), limit of quantification (LOQ), robustness, and system suitability, in accordance with the developed method. Based on the results of this study, it is evident that this method exhibits excellent linearity and a high correlation coefficient over the required concentration range. Based on the accuracy and precision studies, it was concluded that the method has a high degree of reliability and is suitable for routine quality control analysis.