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灵敏且有选择性的生物筛选法,用于检测人血浆中最常用的冠状病毒病药物,即法匹拉韦,及其联合治疗药物美罗培南。

Sensitive and selective bioscreening of the most commonly used coronavirus disease drug, Favipiravir, and its co-administered therapeutic, Meropenem, in human plasma.

机构信息

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

Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Nahda University (NUB), Beni-Suef, Egypt.

出版信息

J Sep Sci. 2022 Oct;45(20):3800-3810. doi: 10.1002/jssc.202200332. Epub 2022 Aug 19.

Abstract

Favipiravir and Meropenem have been concurrently used as directly acting antiviral and antibiotic agents for the treatment of coronavirus disease in human plasma. Accurate and specific reversed phase ultra-performance liquid chromatographic and high-performance thin-layer chromatographic methods were developed and validated for the first time analysis of this combination in spiked human plasma using Cefepime as an internal standard. In the developed ultra-high-performance liquid chromatography method, separation was performed on a BEH C18 column with a mixture of ACN and 0.05 M potassium dihydrogen orthophosphate (pH = 3) in a ratio of 10:90 (v/v) as an eluate. Scanning of the separated peaks was at 298 nm. The developed method showed high sensitivity, and the drugs showed linearity in the range of 5-70 μg/ml for Favipiravir and 2-50 μg/ml for Meropenem. The proposed high-performance thin-layer chromatographic method included the separation using a mixture of ethyl acetate:methanol:deionized water:formic acid (5:4:1.5:0.3, by volume), then spots detection at 300 nm. Methods were investigated for greenness using the eco-scale and national environmental method index tools and were validated according to food and drug administration guidelines. Methods can be applied for bio-analysis and therapeutic drug monitoring studies.

摘要

法匹拉韦和美罗培南已被同时用作治疗人类血浆中冠状病毒病的直接作用抗病毒和抗生素药物。首次开发并验证了准确且特异的反相超高效液相色谱和高效薄层色谱法,以头孢吡肟作为内标,分析该联合用药在人血浆中的浓度。在开发的超高效液相色谱法中,采用 BEH C18 柱,洗脱液为 ACN 和 0.05 M 磷酸二氢钾(pH = 3)的 10:90(v/v)混合物。分离后的峰在 298nm 处进行扫描。所开发的方法具有较高的灵敏度,法匹拉韦的药物浓度在 5-70μg/ml 范围内呈线性,美罗培南的药物浓度在 2-50μg/ml 范围内呈线性。所提出的高效薄层色谱法包括使用乙酸乙酯:甲醇:去离子水:甲酸(5:4:1.5:0.3,体积比)的混合物进行分离,然后在 300nm 处检测斑点。采用生态规模和国家环境方法指数工具对方法的绿色性进行了研究,并根据食品和药物管理局的指南进行了验证。该方法可用于生物分析和治疗药物监测研究。

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