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.
Highlights
Favipiravir is an antiviral drug with molecular formula C5H4FN3O2 (6-fluoro-3-hydroxypyrazıne2-carboxamide) with molecular mass 157.1 and molecular shape shown in Fig. 1. [1]
The HPLC method was developed for the simultaneous determination of favipiravir and peramivir and the determination of their degradation products
Linearity, the limit of detection (LOD), the limit of quantification (LOQ), accuracy, specificity, precision, and robustness were among the validation parameters
Summary
Favipiravir is an antiviral drug with molecular formula C5H4FN3O2 (6-fluoro-3-hydroxypyrazıne2-carboxamide) with molecular mass 157.1 and molecular shape shown in Fig. 1. [1]. The degradation kinetics of favipiravir was studied by LC-MS method under different forced conditions. A new LCMS method was developed for the determination of favipiravir. Two different drugs containing favipiravir were determined from adult patients [7]. The HPLC method was developed for the simultaneous determination of favipiravir and peramivir and the determination of their degradation products. Stress tests are conducted to obtain information about the degradation products and degradation mechanisms of active substances under forced conditions. The stability of the active ingredient in the formulation under storage conditions is very important for the use of medicinal drugs. The impurity profile and stability of a drug substance are important in the safety assessment and production process. Stress tests are performed to obtain information about the degradation products and degradation mechanisms of drug agents under forced conditions [12-14]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
