Development and Validation of an UV-Spectrophotometric and Reverse-Phase High-Performance Liquid Chromatography Method for the Estimation of Umifenovir in Bulk and Tablet Formulations

Abstract

Umifenovir, an antiviral drug that is used to treat influenza, has recently been used in regards to COVID-19 infection. According to a literature survey, no UV technique for the estimation of umifenovir has yet been established; hence, there is an imperative need for a simple analytical method. Additionally, we developed an alternative reverse-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of umifenovir. UV spectrophotometry was carried out at 223 nm absorption maxima using the solvent methanol. A concentration range of 2–12 μg/mL was found to obey Beer’s law, with a correlation coefficient (r²) of 0.9995. A C-18 column (250 mm, 4.6 μm, 5 μm) was used for chromatographic separation using the isocratic mode. The mixture consisted of acetonitrile: 0.1% trimethylamine (pH adjusted to 2.7 by the addition of orthophosphoric acid) 60:40 as the mobile phase with a flow rate of 1 mL/min. The temperature was kept at 25°C, and detection at 223 nm was performed using a PDA detector. The estimated percentage of the drug was close to 100%, corresponding to the label claim of the tablet made in the laboratory. The results and statistical study demonstrated the utility of the current methods in the routine evaluation of umifenovir bulk and formulation.