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利用巴洛沙韦酯对乙酰氧基汞荧光素试剂的猝灭作用测定药物制剂和加标人血浆中的巴洛沙韦酯:绿色度和白度评估

Determination of baloxavir marboxil in pharmaceutical preparations and spiked human plasma using its quenching action on acetoxymercuric fluorescein reagent: Assessment of greenness and whiteness.

作者信息

Nasr Mohamed S, Kaddah Mohamed M Y, Morshedy Samir, Omran Gamal, Talaat Wael

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Damanhour University, Damanhour, 22514, Egypt.

Pharmaceutical and Fermentation Industries Development Center, City of Scientific Research and Technological Applications, New Borg El-Arab, 21934, Alexandria, Egypt.

出版信息

Heliyon. 2024 May 29;10(11):e32120. doi: 10.1016/j.heliyon.2024.e32120. eCollection 2024 Jun 15.

Abstract

A straightforward, reliable, and cost-effective spectrofluorimetric approach has been established for the analysis of baloxavir marboxil (BXM) in raw material, tablets, as well as spiked human plasma. The approach relies on BXM's quenching impact on acetoxymercuric fluorescein (AMF) fluorescence intensity. To improve the reaction, factors such as AMF's concentration, solution's pH, diluting solvents, and reaction time were examined and optimized. Linearity, range, accuracy, precision, LOD, and LOQ were all verified in compliance with ICH criteria. The concentration range was shown to be linear between 0.2 and 2 μg/mL. The technique was effectively utilized for BXM analysis in both its tablet as well as spiked human plasma, with mean % recoveries of 101 ± 0.36 and 98.77 ± 0.65, respectively. Two assessment models (AGREE and RGB-12) were used to compare the proposed process's greenness and sustainability to four previously published chromatographic techniques. Higher green and sustainability qualities were declared by the suggested approach than by earlier ones.

摘要

已建立一种直接、可靠且经济高效的荧光分光光度法,用于分析原料药、片剂以及加标人血浆中的巴洛沙韦马波西酯(BXM)。该方法基于BXM对乙酰氧基汞荧光素(AMF)荧光强度的猝灭作用。为优化反应,对AMF浓度、溶液pH值、稀释溶剂和反应时间等因素进行了考察和优化。线性、范围、准确度、精密度、检测限和定量限均按照国际人用药品注册技术协调会(ICH)标准进行了验证。浓度范围在0.2至2μg/mL之间呈线性关系。该技术有效地用于片剂和加标人血浆中BXM的分析,平均回收率分别为101±0.36和98.77±0.65。使用两种评估模型(AGREE和RGB - 12)将所提出方法的绿色度和可持续性与之前发表的四种色谱技术进行比较。结果表明,所建议的方法比之前的方法具有更高的绿色度和可持续性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a3a/11190548/da4d4b904450/gr1.jpg

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