Development and Validation of UPLC-MS / MS Method for Obtaining Favipiravir Tablet Dosage form and Evaluation of its Behavior Under forced Conditions

Abstract

Aims: Favipiravir (FVP) is a drug developed against RNA viruses. It is a drug that is used actively in the treatment of coronavirus. In vitro and in vivo investigations have shown that it inhibits the virus. In this study, a recovery study of tablet formulations was carried out by developing a UPLC-MS/MS method, which is used extensively in pandemic conditions. In addition, stability studies of favipiravir agent under forced conditions were conducted. The validated method is selective, robust, simple and applicable for tablet analysis. C18 (4.6 mm × 50 mm, 2.7 μm) column was used as the stationary phase and water-methanol (80-20 v/v) containing 0.1% formic acid was used as the mobile phase. UPLC optimization; It was conducted at a wavelength of 222 nm and a flow rate of 0.8 mL/min at 40 °C, retention time was 1.155 min. The electrospray jet stream ionization source was analyzed using mass spectrometry in negative ion mode. The molecular peak for Favipiravir was [M-1] 155.9, and the daughter ion determined 112.6. The stability test method was carried out in accordance with the ICH procedure. Reaction and degradation rates of the active substance under various forced conditions (acidic, basic, oxidative, UV light and thermal conditions) were investigated. The products formed by the decomposition of the active substance under stress conditions were determined by mass spectroscopy.