新型分光光度法分析药物制剂、人血浆和环境水样中索非那新和西洛多辛的方法:绿色和实用性评价。

IF 3.8 2区 化学 Q1 BIOCHEMICAL RESEARCH METHODS
Aya Saad Radwan, Mohamed Hefnawy, Talha Bin Emran, Mohamed M Salim
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引用次数: 0

摘要

最近西洛多辛(SOD)和琥珀酸索利那新(SOF)的固定剂量联合治疗膀胱过度活动综合征的批准,创造了对创新分析方法的需求,使其能够同时定量。本研究建立了7种新颖、环保、经济的分光光度法同时测定SOD和SOF。这些方法克服了传统技术的局限性,消除了对复杂仪器、劳动密集型程序和大量有害有机溶剂的需求,提供了一种可持续的、可获得的分析替代方案。直接紫外法(method I)可在270 nm (1.0 ~ 15.0 μg/mL)波段选择性定量SOD,光谱完全独立于SOF。考虑到SOD与SOF光谱存在较大重叠,创新性地采用双波长、一阶导数、比例光谱差、比例光谱一阶导数、比例减法、吸收因子等6种先进的紫外光谱方法对SOD (1.0 ~ 12.0 μg/mL)进行精确定量。通过对复方制剂和人血浆中SOD和SOF的准确分析,证明了该方法的适用性,且不受辅料或内源性化合物的干扰。所提出的方法被设计成多功能的,允许它们在各种分析设置中的应用。该方法已成功验证并应用于复方片剂的质量控制分析、生物用加标血浆中超氧化物歧化酶的测定以及不同水基质环境监测。这种广泛的适用性突出了方法的通用性,鲁棒性和在常规实验室分析中的实用价值。此外,它们在与环境相关的水样品中的表现突出了它们的敏感性和稳健性,产生了出色的回收率和低%RSD值。使用GAPI、AGREE和最近引入的CACI工具对方法的绿色和实用性进行了严格评估,所有这些都证实了这些方法的卓越的生态友好性和经济可行性。完全符合ICH Q2(R2)指南进一步确认了其在日常质量控制和环境监测中的有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Novel spectrophotometric approaches for analysis of solifenacin and silodosin in pharmaceutical preparations, human plasma, and environmental water samples: assessment of the methods' greenness and practicality.

The recent approval of a fixed-dose combination of silodosin (SOD) and solifenacin succinate (SOF) for overactive bladder syndrome has created a need for innovative analytical approaches enabling their simultaneous quantification. In this work, seven novel, eco-friendly, and cost-efficient spectrophotometric methods were developed for the concurrent determination of SOD and SOF. These methods overcome the limitations of conventional techniques by eliminating the need for complex instrumentation, labor-intensive procedures, and large volumes of hazardous organic solvents, offering a sustainable and accessible analytical alternative. A direct UV method (Method I) enabled selective quantification of SOD at 270 nm (1.0-15.0 μg/mL) with complete spectral independence from SOF. Given the substantial overlap between SOD and SOF spectra, six advanced UV-based methods including dual-wavelength, first derivative, ratio spectra difference, first derivative of ratio spectra, ratio subtraction, and absorption factor were innovatively applied for the accurate quantification of SOF (1.0-12.0 μg/mL). The applicability of the proposed methods was demonstrated through accurate analysis of SOD and SOF in combined pharmaceutical formulations and spiked human plasma, with no interference from excipients or endogenous compounds. The proposed methods were designed to be multifunctional, allowing their application in various analytical settings. They were successfully validated and applied for the quality control analysis of co-formulated pharmaceutical tablets, determination of SOD in spiked human plasma for biological use, and for environmental monitoring in different water matrices. This broad applicability highlights the methods' versatility, robustness, and practical value in routine laboratory analysis. Furthermore, their performance in environmentally relevant aqueous samples underscored their sensitivity and robustness, yielding excellent recovery rates and low %RSD values. Method greenness and practicality were critically evaluated using the GAPI, AGREE, and the recently introduced CACI tool, all confirming the exceptional eco-friendliness and economic viability of the approaches. Full compliance with ICH Q2(R2) guidelines further affirms their validity for routine quality control and environmental monitoring.

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来源期刊
CiteScore
8.00
自引率
4.70%
发文量
638
审稿时长
2.1 months
期刊介绍: Analytical and Bioanalytical Chemistry’s mission is the rapid publication of excellent and high-impact research articles on fundamental and applied topics of analytical and bioanalytical measurement science. Its scope is broad, and ranges from novel measurement platforms and their characterization to multidisciplinary approaches that effectively address important scientific problems. The Editors encourage submissions presenting innovative analytical research in concept, instrumentation, methods, and/or applications, including: mass spectrometry, spectroscopy, and electroanalysis; advanced separations; analytical strategies in “-omics” and imaging, bioanalysis, and sampling; miniaturized devices, medical diagnostics, sensors; analytical characterization of nano- and biomaterials; chemometrics and advanced data analysis.
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