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本文引用的文献

1
Novel spectrofluorimetric approach for determination of ledipasvir through UV-irradiation: application to biological fluids, pharmacokinetic study and content uniformity test.通过紫外线照射测定来迪帕司韦的新型荧光分光光度法:在生物体液中的应用、药代动力学研究及含量均匀度测试
RSC Adv. 2019 Oct 24;9(59):34256-34264. doi: 10.1039/c9ra07949a. eCollection 2019 Oct 23.
2
Novel environment friendly TLC-densitometric method for the determination of anti-coronavirus drugs "Remdesivir and Favipiravir": Green assessment with application to pharmaceutical formulations and human plasma.用于测定抗冠状病毒药物“瑞德西韦和法匹拉韦”的新型环保薄层色谱-密度测定法:应用于药物制剂和人体血浆的绿色评估
Microchem J. 2022 Mar;174:107101. doi: 10.1016/j.microc.2021.107101. Epub 2021 Dec 18.
3
Green and sensitive spectrofluorimetric determination of Remdesivir, an FDA approved SARS-CoV-2 candidate antiviral; application in pharmaceutical dosage forms and spiked human plasma.绿色敏感的荧光光度法测定瑞德西韦,一种获得 FDA 批准的 SARS-CoV-2 候选抗病毒药物;在药物制剂和加标人血浆中的应用。
Anal Methods. 2021 Jun 21;13(23):2596-2602. doi: 10.1039/d1ay00469g. Epub 2021 May 21.
4
Therapeutic strategies to fight COVID-19: Which is the status artis?抗击 COVID-19 的治疗策略:现状如何?
Br J Pharmacol. 2022 May;179(10):2128-2148. doi: 10.1111/bph.15452. Epub 2021 May 7.
5
Micellar sensitized Resonance Rayleigh Scattering and spectrofluorometric methods based on isoindole formation for determination of Eflornithine in cream and biological samples.胶束敏化共振瑞利散射和基于异吲哚形成的光谱荧光法测定乳膏和生物样品中依氟鸟氨酸。
Spectrochim Acta A Mol Biomol Spectrosc. 2021 Sep 5;258:119806. doi: 10.1016/j.saa.2021.119806. Epub 2021 Apr 8.
6
Development and validation of a simple, selective, and sensitive LC-MS/MS assay for the quantification of remdesivir in human plasma.开发并验证了一种简单、选择性强、灵敏度高的液相色谱-串联质谱法,用于人血浆中瑞德西韦的定量分析。
J Chromatogr B Analyt Technol Biomed Life Sci. 2021 May 1;1171:122641. doi: 10.1016/j.jchromb.2021.122641. Epub 2021 Mar 10.
7
Covid-19: The E484K mutation and the risks it poses.新冠病毒:E484K突变及其带来的风险。
BMJ. 2021 Feb 5;372:n359. doi: 10.1136/bmj.n359.
8
Validation of LC-MS/MS methods for determination of remdesivir and its metabolites GS-441524 and GS-704277 in acidified human plasma and their application in COVID-19 related clinical studies.LC-MS/MS 法测定酸性人血浆中瑞德西韦及其代谢物 GS-441524 和 GS-704277 的方法学验证及其在 COVID-19 相关临床研究中的应用。
Anal Biochem. 2021 Mar 15;617:114118. doi: 10.1016/j.ab.2021.114118. Epub 2021 Jan 26.
9
Rapid determination of remdesivir (SARS-CoV-2 drug) in human plasma for therapeutic drug monitoring in COVID-19-Patients.快速测定人血浆中的瑞德西韦(治疗新冠病毒的药物),用于新冠肺炎患者的治疗药物监测。
Process Biochem. 2021 Mar;102:150-156. doi: 10.1016/j.procbio.2020.12.014. Epub 2020 Dec 25.
10
Remdesivir: First Approval.瑞德西韦:首次批准
Drugs. 2020 Sep;80(13):1355-1363. doi: 10.1007/s40265-020-01378-w.

光谱荧光法测定小瓶和加标人血浆中的抗新冠病毒药物瑞德西韦。

Spectrofluorimetric determination of the anti-Covid 19 agent, remdesivir, in vials and spiked human plasma.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, Egypt.

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

出版信息

Luminescence. 2022 Jul;37(7):1192-1199. doi: 10.1002/bio.4274. Epub 2022 May 22.

DOI:10.1002/bio.4274
PMID:35548893
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9348023/
Abstract

Following the sudden widespread of the novel coronavirus (COVID-19) which first appeared in Wuhan city. Remdesivir (REM) was the first medicine licensed by the US Food and Drug Administration (FDA) for COVID-19 infected hospitalized patients. Hence, there was an urgent demand for the optimization of efficient selective and sensitive methods to be developed for the determination of REM in pharmaceuticals as well as biological samples. A sensitive and simple green spectrofluorimetric method has been developed to determine REM in pharmaceutical formulation, in addition to, spiked human plasma. The technique involves measuring the native fluorescence of REM in distilled water at 410 nm followed by excitation at 241 nm, giving a linear relationship over the range 50.00-500.00 ng/mL, and then improving the sensitivity of REM through micellar formation using 2.00% w/v sodium dodecyl sulfate (SDS). A linear relationship has been obtained over the range 10.00-350.00 ng/mL having detection and quantitation limits of 2.34 and 7.10 ng/mL, respectively. Different analytical parameters have been carefully studied. A validation study has been conducted successfully in accordance with the FDA and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The developed methods' greenness was assessed utilizing a greenness profile and analytical eco-scale standards. Both methods were discovered to be environmentally friendly and could be successfully used for the determination of the studied drugs in pharmaceutical formulation and human plasma with good accuracy and high precision. As a result, the developed spectrofluorimetric methods could be ideally suited for determination of REM in quality control and medicinal laboratories.

摘要

新型冠状病毒(COVID-19)最初出现在武汉市后突然广泛传播。瑞德西韦(REM)是美国食品和药物管理局(FDA)首次批准用于治疗 COVID-19 感染住院患者的药物。因此,迫切需要优化高效的选择性和敏感性方法,以用于药物和生物样本中 REM 的测定。已经开发了一种灵敏且简单的绿色分光荧光法来测定药物制剂以及加标人血浆中的 REM。该技术涉及在蒸馏水(REM 在其中发出固有荧光)中于 410nm 处测量 REM 的荧光,然后在 241nm 处激发,在 50.00-500.00ng/mL 范围内给出线性关系,然后通过使用 2.00%w/v 十二烷基硫酸钠(SDS)形成胶束来提高 REM 的灵敏度。在 10.00-350.00ng/mL 范围内获得了线性关系,检测限和定量限分别为 2.34 和 7.10ng/mL。仔细研究了不同的分析参数。已根据 FDA 和国际人用药物技术要求协调理事会(ICH)指南成功进行了验证研究。利用绿色分析档案和分析生态标准评估了开发方法的绿色性。发现这两种方法均具有环保性,可以成功地用于药物制剂和人血浆中研究药物的测定,具有良好的准确性和高精度。因此,所开发的分光荧光法非常适合于质量控制和药物实验室中 REM 的测定。