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首例获批的抗病毒药物瑞德西韦与左羟丙哌嗪联用治疗新冠肺炎的绿色同步荧光光谱分析:在其药物剂型及加标人血浆中的应用

Green synchronous spectrofluorimetric analysis of remdesivir, the first approved antiviral, with levodropropizine as add-on therapy for covid-19: application in their pharmaceutical dosage form, and spiked human plasma.

作者信息

El-Adl Sobhy M, El-Shanawani Abdalla A, Madbouly Eman A, Abdelkhalek Ahmed S

机构信息

Department of Medicinal Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt.

出版信息

BMC Chem. 2025 May 2;19(1):115. doi: 10.1186/s13065-025-01480-8.

DOI:10.1186/s13065-025-01480-8
PMID:40317008
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12048920/
Abstract

It was the first time that a spectrofluorimetric approach for the simultaneous analysis of remdesivir and levodropropizine had been achieved. This study aims to propose an accurate and sensitive second-derivative synchronous spectrofluorimetric approach for measurement of remdesivir and levodropropizine in different matrices simultaneously without the need for prior separation. The proposed approach measured the synchronous fluorescence intensity of pharmaceuticals under research at a constant wavelength difference (Δλ) = 130 nm. For the quantitative analysis of remdesivir and levodropropizine, the peak amplitudes of the second derivative were measured at 390 and 399 nm, respectively. The procedure was completely validated and demonstrated outstanding linearity in the concentration ranges of 5-150 ng mL and 10-600 ng mL for remdesivir and levodropropizine, respectively. The new method was used to quantitatively analyze both drugs in their pharmaceutical dosage form, synthetically formulated mixture and spiked human plasma. A statistical comparison of the results with other published analytical techniques revealed no significant difference. The validation of the procedure was successfully completed in compliance with ICH guidelines. In terms of greenness, EcoScale and GAPI greenness tools were used to evaluate the analytical methodology.

摘要

这是首次实现采用荧光分光光度法同时分析瑞德西韦和左羟丙哌嗪。本研究旨在提出一种准确且灵敏的二阶导数同步荧光分光光度法,用于同时测定不同基质中的瑞德西韦和左羟丙哌嗪,无需预先分离。所提出的方法在恒定波长差(Δλ) = 130 nm下测量所研究药物的同步荧光强度。对于瑞德西韦和左羟丙哌嗪的定量分析,分别在390和399 nm处测量二阶导数的峰幅度。该方法经过全面验证,在瑞德西韦浓度范围为5 - 150 ng/mL以及左羟丙哌嗪浓度范围为10 - 600 ng/mL时表现出出色的线性。该新方法用于定量分析药物剂型、合成配制混合物和加标人血浆中的两种药物。将结果与其他已发表分析技术进行统计比较,未发现显著差异。该方法的验证已按照国际协调会议(ICH)指南成功完成。在绿色度方面,使用EcoScale和GAPI绿色度工具评估分析方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/c0f1f2f06cda/13065_2025_1480_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/a7174d9dac30/13065_2025_1480_Sch1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/8e44e9bde7d1/13065_2025_1480_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/ce2c84e15c9d/13065_2025_1480_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/e3ccaf5427d8/13065_2025_1480_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/d084d5a4af43/13065_2025_1480_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/b38801acded2/13065_2025_1480_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/c0f1f2f06cda/13065_2025_1480_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/a7174d9dac30/13065_2025_1480_Sch1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/8e44e9bde7d1/13065_2025_1480_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/ce2c84e15c9d/13065_2025_1480_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/e3ccaf5427d8/13065_2025_1480_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/d084d5a4af43/13065_2025_1480_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/b38801acded2/13065_2025_1480_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/060e/12048920/c0f1f2f06cda/13065_2025_1480_Fig6_HTML.jpg

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