Development and Validation of Favipiravir Severe Acute Respiratory Syndrome Coronavirus 2 Drug by Dissolution Method with Filter Compatibility Study

Abstract

Favipiravir drug is fitted into antiviral medication criteria and mainly used in the treatment of influenza. The mechanism is associated with choosy inhibition of viral ribonucleic acid-dependent ribonucleic acid polymerase. Development and validation of dissolution method and filter compatibility studies are conducted with reverse phase ultra-performance liquid chromatography method for the quantitative analysis. The validation of this method was performed as per International Council for Harmonisation Q2 (R1) guidelines with the optimized experimental conditions. The proposed method was achieved on Acquity ultra-performance liquid chromatography HSS C18 (100 mm×1.8 μ) column and temperature maintained at 30° and run time was 8 min. The mobile phase consists of A-Methanol, B-0.1 % Trifluoroacetic acid (v/v) in water (pH=4.8). The injection volume of samples was 1 μl and ultraviolet detection was carried out at 210 nm. Linearity ranges were covered from 1 % to 300 % of the sample concentration level. The newly developed dissolution profile will show good repeatability and reproducibility in solid dosage forms and proved the filter compatibility studies. The projected method has capable to produce swift retention time and maintained well percentage recoveries throughout the dissolution profile. Hence this method can be used in customary quantitative analysis in quality control department for solid dosage forms and active pharmaceutical ingredients.