Multivariate Optimization for Determination of Favipiravir, a SARS-CoV-2 Molecule, by the Reverse-Phase Liquid Chromatographic Method Using a QbD Approach.

The object of the analytical work is to develop an analytical multivariate optimization for the determination of Favipiravir (FAV), a SARS-CoV-2 molecule, by the reverse-phase liquid chromatographic method using the analytical quality by design approach. FAV is used as an antiviral drug. Box-Behnken design is utilized for the optimization of the experiment and to identify the critical method parameters like the volume of acetonitrile, temperature and flow rate. Further, these factors are used to design the suitable mathematical models and illustrate their effect on various responses. This newly developed method utilized C18 column (5μm, 100 × 4.6 mm) and a temperature of 40°C with a flow rate of 0.5 mL/min. The mobile phase is composed of acetonitrile and ammonium acetate buffer (pH 4), in the ratio of 20:80v/v and the wavelength of HPLC UV-Detector was fixed to 323nm. This method is validated according to International Council for Harmonization Q2 (R1) guidelines. The System suitability is performed and the retention time of Favipiravir is 3.4min. The linearity range is obtained at 0.062 - 4 μg/mL with a correlation coefficient (r2 = 0.9979). The recovery is found to be in the range of 98.84-100%. Thus, the intended method is found to be simple and robust.