Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool L7 8TX, UK.
Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool L7 8TX, UK.
J Pharm Biomed Anal. 2023 Sep 5;233:115436. doi: 10.1016/j.jpba.2023.115436. Epub 2023 May 2.
Favipiravir (FVP) is a broad-spectrum antiviral that selectively inhibits viral RNA-dependent RNA polymerase, first trialled for the treatment of influenza infection. It has been shown to be effective against a number of RNA virus families including arenaviruses, flaviviruses and enteroviruses. Most recently, FVP has been investigated as a potential therapeutic for severe acute respiratory syndrome coronavirus 2 infection. A liquid chromatography tandem mass spectrometry method for the quantification of FVP in human plasma has been developed and validated for use in clinical trials investigating favipiravir as treatment for coronavirus disease-2019. Samples were extracted by protein precipitation using acetonitrile, using C, N- Favipiravir as internal standard. Elution was performed on a Synergi Polar-RP 150 × 2.1 mm 4 µm column using a gradient mobile phase programme consisting of 0.2% formic acid in water and 0.2% formic acid in methanol. The assay was validated over the range 500-50,000 ng/mL; this method was found to be precise and accurate and recovery of FVP from the matrix was high. Stability experiments confirmed and expanded on the known stability of FVP, including under heat treatment and for a period of 10 months at - 80 °C.
法匹拉韦（FVP）是一种广谱抗病毒药物，选择性地抑制病毒 RNA 依赖性 RNA 聚合酶，最初用于治疗流感感染。它已被证明对包括沙粒病毒科、黄病毒科和肠道病毒在内的多种 RNA 病毒家族有效。最近，FVP 已被研究作为严重急性呼吸综合征冠状病毒 2 感染的潜在治疗药物。已经开发并验证了一种用于人血浆中 FVP 定量的液相色谱串联质谱法，用于研究法匹拉韦作为治疗 2019 年冠状病毒病的临床试验。样品通过使用乙腈进行蛋白质沉淀提取，使用 C，N-法匹拉韦作为内标。洗脱在 Synergi Polar-RP 150×2.1mm 4µm 柱上进行，使用包含 0.2%甲酸的水和 0.2%甲酸的甲醇作为梯度流动相程序。该测定法在 500-50000ng/mL 范围内进行验证；该方法被发现具有良好的精密度和准确性，并且从基质中回收 FVP 的效率较高。稳定性实验证实并扩展了 FVP 的已知稳定性，包括热处理和在-80°C 下保存 10 个月的稳定性。
