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一种环境可持续的同步荧光光谱法,结合二阶导数信号处理,用于同时测定药物和血浆样品中的维帕他韦和西米普韦。

An environmentally sustainable synchronous spectrofluorimetric method coupled with second derivative signal processing for simultaneous determination of velpatasvir and simeprevir in pharmaceutical and plasma samples.

机构信息

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, 11751 Nasr City, Cairo, Egypt.

Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2025 Feb 5;326:125202. doi: 10.1016/j.saa.2024.125202. Epub 2024 Sep 23.

Abstract

Velpatasvir and simeprevir are two direct acting antivirals that are often used in combination with sofosbuvir to treat HCV infections. Herein, an environmentally benign spectrofluorimetric method was developed for simultaneous quantification of velpatasvir and simeprevir in pharmaceutical and plasma samples. To address the issue of overlapping fluorescence spectra presented by these compounds, this method integrates synchronous fluorescence and second-derivative spectroscopy. By employing the second derivative of the synchronous fluorescence spectra measured at Δλ of 140 nm, the accurate determination of velpatasvir at 400 nm and simeprevir at 426 nm was achieved without any interference. Different experimental parameters affecting the synchronous fluorescence of the studied drugs were carefully optimized. The plots of second-derivative amplitudes against concentrations showed linearity in the range of 5-400 ng/mL for velpatasvir and 80-800 ng/mL for simeprevir. The method was very sensitive, with lower detection limits of 1.11 ng/mL and 25.40 ng/mL, and quantification limits of 3.36 ng/mL and 76.96 ng/mL for velpatasvir and simeprevir, respectively.The method was effectively used to determine velpatasvir and simeprevir simultaneously in their pure forms, pharmaceutical dosage forms, and human plasma with no interference. The suggested technique was additionally evaluated for its eco-friendliness through the utilization of the Analytical GREEnness (AGREE) and Green Analytical Procedure Index (GAPI) evaluation metrics, revealing that the method is indeed sustainable.

摘要

维帕他韦和西美瑞韦是两种常用于与索磷布韦联合治疗 HCV 感染的直接作用抗病毒药物。在此,开发了一种环境友好的分光荧光法,用于同时定量检测药物和血浆样品中的维帕他韦和西美瑞韦。为了解决这些化合物荧光光谱重叠的问题,该方法结合了同步荧光和二阶导数光谱法。通过测量同步荧光光谱时 Δλ 为 140nm 的二阶导数,可以在没有任何干扰的情况下,准确地在 400nm 处测定维帕他韦,在 426nm 处测定西美瑞韦。仔细优化了影响研究药物同步荧光的不同实验参数。二阶导数幅度与浓度的关系图显示,维帕他韦的线性范围为 5-400ng/mL,西美瑞韦的线性范围为 80-800ng/mL。该方法非常灵敏,维帕他韦和西美瑞韦的检测限分别为 1.11ng/mL 和 25.40ng/mL,定量限分别为 3.36ng/mL 和 76.96ng/mL。该方法有效地用于同时测定纯品、药物制剂和人血浆中的维帕他韦和西美瑞韦,无干扰。通过使用分析绿色度(AGREE)和绿色分析程序指数(GAPI)评价指标,进一步评估了该技术的生态友好性,表明该方法确实具有可持续性。

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