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一种新开发的用于测定加标人血浆中瑞德西韦、法匹拉韦和地塞米松的高效薄层色谱法:与已发表方法的比较

A newly developed high-performance thin layer chromatographic method for determination of remdesivir, favipiravir and dexamethasone, in spiked human plasma: comparison with the published methods.

作者信息

Abdelfatah Rehab M, Abdelmomen Esraa H, Abdelaleem Eglal A, Abdelmoety Refaat H, Emam Aml A

机构信息

Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Nile Valley University, Faiyum, Egypt.

出版信息

BMC Chem. 2025 Jan 7;19(1):7. doi: 10.1186/s13065-024-01366-1.

Abstract

Co-administration of COVID-19 RNA polymerase inhibitors, remdesivir and favipiravir, has synergistic benefits. Together they reduce viral load and inflammation more effectively than either drug used alone. Corticosteroids like dexamethasone are used alongside antivirals in multidrug combination regimens. A new HPTLC method was utilized to isolate and quantitatively determine the three medicines of the COVID-19 therapeutic protocol, remdesivir, favipiravir and dexamethasone, using the anticoagulant apixaban as an internal standard in human plasma. The mobile phase system used a solvent mixture of ethyl acetate, hexane, and acetic acid (9:1:0.3, by volume). At 254 nm, well-resolved spots with Rf values of 0.3 for remdesivir, 0.64 for dexamethasone, and 0.77 for favipiravir have been observed. To ensure compliance with FDA regulations, a validation study was conducted. Quantitation limits as low as 0.1 µg/band have been achieved with remdesivir and dexamethasone, and 0.2 µg/band with favipiravir, demonstrating excellent sensitivities. From 97.07% to 102.77%, the drugs were recovered from human plasma that had been artificially spiked. The whiteness of the method has been assessed using RGB 12 algorithm and a percentage of whiteness of 95.6% has been obtained.

摘要

新冠病毒RNA聚合酶抑制剂瑞德西韦和法匹拉韦联合使用具有协同效益。它们共同作用时比单独使用任何一种药物都能更有效地降低病毒载量和炎症。地塞米松等皮质类固醇在多药联合治疗方案中与抗病毒药物一起使用。采用一种新的高效薄层色谱法,以抗凝剂阿哌沙班作为人血浆中的内标,分离并定量测定新冠治疗方案中的三种药物,即瑞德西韦、法匹拉韦和地塞米松。流动相系统使用乙酸乙酯、己烷和乙酸的混合溶剂(体积比为9:1:0.3)。在254nm波长下,观察到分辨率良好的斑点,瑞德西韦的比移值为0.3,地塞米松为0.64,法匹拉韦为0.77。为确保符合美国食品药品监督管理局的规定,进行了一项验证研究。瑞德西韦和地塞米松的定量限低至0.1μg/条带,法匹拉韦为0.2μg/条带,显示出优异的灵敏度。在人工加标的人血浆中,药物回收率为97.07%至102.77%。使用RGB 12算法评估了该方法的白度,获得了95.6%的白度百分比。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4958/11705924/d6322241917b/13065_2024_1366_Fig1_HTML.jpg

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