ABSTRACT
Simple, accurate and robust analytical methods have been developed and validated for the determination of favipiravir (FVPR) by RP-HPLC and UV spectroscopy techniques as per the ICH guidelines. In the RP-HPLC method for FVPR determination, the mobile phase was ammonium acetate buffer pH 6.5 in pump Aand methanol in pump B. The C18 (Sunfire) 5 µm, 4.6 × 250 mm column was used as a stationary phase, and the detection wavelength was at 323 nm. Under these conditions, FVPR was eluted as a sharp peak at 2.65 min and the overall time taken for each injection was 10 min. In case of the UV spectroscopy method, standard FVPR solutions were prepared with pure ethanol and scanned from 250 to 400 nm and a flourishing spectrum was obtained at 323 nm. Hence, the wavelength of 323 nm was fixed for the whole process of validation in both techniques. The limit of detection (LOD) and limit of quantification (LOQ) in the RP-HPLC method were 1.0 and 3.5 µg/mL, respectively, and the linearity was established in the 10 to 50 µg/mL range. In the UV spectroscopy method, the LOD and LOQ values were found to be 3.5 and 12 µg/mL, respectively, and the linearity was established within 20 to 60 µg/mL range. The regression coefficient was found to exceed 0.999 in both methods. The proposed RP-HPLC and UV spectroscopy techniques are simple, accurate, rugged and robust.