Emam Aml A, Abdelaleem Eglal A, Abdelmomen Esraa H, Abdelmoety Refaat H, Abdelfatah Rehab M
Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.
Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Nahda University (NUB), Beni-Suef, Egypt.
Microchem J. 2022 Aug;179:107580. doi: 10.1016/j.microc.2022.107580. Epub 2022 May 13.
Innovative therapeutic protocols to the rapidly spreading coronavirus disease (COVID19) epidemic is highly required all across the world. As demonstrated by clinical studies, Favipiravir (FVP) and Remdesivir (REM) are new antiviral medicines that are effective against COVID-19. REM is the first FDA approved antiviral medicine against COVID-19. In addition to antivirals, corticosteroids such as dexamethasone (DEX), and anticoagulants such as apixaban (PX) are used in multidrug combinations protocols. This work develops and validates simple and selective screening of the four medicines of COVID -19 therapeutic protocol. FVP, REM, DEX, and PX as internal standard in human plasma using UPLC method by C18 column and methanol, acetonitrile, and water acidified by orthophosphate (pH = 4) in a ratio of (15: 35: 50, by volume) as an eluate flowing at 0.3 mL/min. The eluent was detected at 240 nm. The method was linear over (0.1-10 μg/mL) for each of FVP, REM, and DEX. The validation of the UPLC method was assessed in accordance with FDA guidelines. The method can detect as low as down to 0.1 μg/mL for all. The recoveries of the drugs in spiked human plasma ranged from 97.67 to 102.98 percent. Method accuracy and precision were assessed and the drugs showed good stability. The method was proven to be green to the environment after greenness checking by greenness profile and Eco-Scale tool.
全球迫切需要针对迅速蔓延的冠状病毒病（COVID-19）疫情的创新治疗方案。临床研究表明，法匹拉韦（FVP）和瑞德西韦（REM）是对COVID-19有效的新型抗病毒药物。REM是首个获得美国食品药品监督管理局（FDA）批准用于治疗COVID-19的抗病毒药物。除了抗病毒药物外，地塞米松（DEX）等皮质类固醇和阿哌沙班（PX）等抗凝剂也用于多药联合治疗方案。本研究开发并验证了一种简单且具有选择性的方法，用于筛选COVID-19治疗方案中的四种药物。采用超高效液相色谱（UPLC）法，以C18柱，流动相为甲醇、乙腈和用正磷酸盐酸化的水（pH = 4），体积比为（15:35:50），流速为0.3 mL/min，以内标法测定人血浆中的FVP、REM、DEX和PX。在240 nm处检测洗脱液。该方法对FVP、REM和DEX的线性范围均为（0.1 - 10 μg/mL）。按照FDA指南对UPLC方法进行了验证。该方法对所有药物的最低检测限低至0.1 μg/mL。加标人血浆中药物的回收率在97.67%至102.98%之间。评估了方法的准确性和精密度，结果表明药物具有良好的稳定性。通过绿色度曲线和生态尺度工具进行绿色度检查后，证明该方法对环境友好。
