Analytical-Quality-by-Design Fluoroprobes for Quantitation of Entecavir and Penciclovir in Spiked Human Plasma and Content Uniformity Testing: Insights of DNA Mismatching, Three-Colors Assessment and Sustainability Profiling

IF 3.2 4区化学 Q2 CHEMISTRY, ANALYTICAL

Luminescence Pub Date : 2025-03-03 DOI:10.1002/bio.70128

Sarah S. Saleh, Ahmed Samir, Omnia A. El-Naem

{"title":"Analytical-Quality-by-Design Fluoroprobes for Quantitation of Entecavir and Penciclovir in Spiked Human Plasma and Content Uniformity Testing: Insights of DNA Mismatching, Three-Colors Assessment and Sustainability Profiling","authors":"Sarah S. Saleh, Ahmed Samir, Omnia A. El-Naem","doi":"10.1002/bio.70128","DOIUrl":null,"url":null,"abstract":"<div>\n \n <p>Entecavir and penciclovir are nucleoside-analog antiviral drugs structurally related to guanine that act by inhibiting the active viral replication process. Through this study, the quantitation of both drugs was carried out using two fluorescent probes, referred to as fluoroprobes. The first type was prepared by the addition of surfactants such as Tween 80 and sodium dodecyl sulfate (micelle-enhanced fluoroprobes), while the second type includes the formation of a tertiary complex of drug-terbium-DNA (Tb-DNA fluoroprobes). The preparation of the fluoroprobes was optimized using analytical quality by design (AQbD) via I-optimal design. A positive effect of the selected antiviral drugs on DNA mismatching was observed. The analytical procedures were validated according to ICH guidelines with a linearity range of 2.0–40.0 μM and 25.0–300.0 nM for micelle-enhanced and Tb-DNA fluoroprobes, respectively. The analytical procedures were evaluated in compliance with the three-color (GBW) assessments: greenness (using AGREE and ComplexGAPI metrics), blueness (using the BAGI tool), and whiteness (using the RGB algorithm). The sustainability profiles were established using the efficient-valid-green (EVG) framework. Both types of fluoroprobes were successfully applied to quantify entecavir and penciclovir in content uniformity testing and spiked human plasma as a simpler and cheaper alternative to hyphenated analytical techniques.</p>\n </div>","PeriodicalId":49902,"journal":{"name":"Luminescence","volume":"40 3","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Luminescence","FirstCategoryId":"92","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/bio.70128","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}

引用次数: 0

Abstract

Entecavir and penciclovir are nucleoside-analog antiviral drugs structurally related to guanine that act by inhibiting the active viral replication process. Through this study, the quantitation of both drugs was carried out using two fluorescent probes, referred to as fluoroprobes. The first type was prepared by the addition of surfactants such as Tween 80 and sodium dodecyl sulfate (micelle-enhanced fluoroprobes), while the second type includes the formation of a tertiary complex of drug-terbium-DNA (Tb-DNA fluoroprobes). The preparation of the fluoroprobes was optimized using analytical quality by design (AQbD) via I-optimal design. A positive effect of the selected antiviral drugs on DNA mismatching was observed. The analytical procedures were validated according to ICH guidelines with a linearity range of 2.0–40.0 μM and 25.0–300.0 nM for micelle-enhanced and Tb-DNA fluoroprobes, respectively. The analytical procedures were evaluated in compliance with the three-color (GBW) assessments: greenness (using AGREE and ComplexGAPI metrics), blueness (using the BAGI tool), and whiteness (using the RGB algorithm). The sustainability profiles were established using the efficient-valid-green (EVG) framework. Both types of fluoroprobes were successfully applied to quantify entecavir and penciclovir in content uniformity testing and spiked human plasma as a simpler and cheaper alternative to hyphenated analytical techniques.

查看原文本刊更多论文

用于加标人血浆中恩替卡韦和喷昔洛韦定量的分析质量设计荧光探针和含量均匀性测试：DNA不匹配，三色评估和可持续性分析的见解

恩替卡韦和喷昔洛韦是核苷类抗病毒药物，结构上与鸟嘌呤相关，通过抑制活跃的病毒复制过程起作用。通过本研究，这两种药物的定量使用两种荧光探针，称为荧光探针。第一种类型是通过添加表面活性剂如Tween 80和十二烷基硫酸钠（胶束增强氟探针）制备的，而第二种类型包括形成药物-铽- dna三级配合物（Tb-DNA氟探针）。通过i -最优设计，采用分析质量设计法（AQbD）对荧光探针的制备进行优化。所选择的抗病毒药物对DNA错配有积极作用。根据ICH指南，胶束增强和Tb-DNA荧光探针的线性范围分别为2.0 ~ 40.0 μM和25.0 ~ 300.0 nM。分析程序按照三色（GBW）评估进行评估：绿色（使用AGREE和ComplexGAPI指标）、蓝色（使用BAGI工具）和白色（使用RGB算法）。使用高效有效绿色（EVG）框架建立可持续性概况。两种类型的氟探针都成功地应用于定量恩替卡韦和喷昔洛韦的含量均匀性测试和加标人血浆，作为一种更简单和更便宜的替代联用分析技术。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Luminescence 生物-生化与分子生物学

CiteScore

5.10

自引率

13.80%

发文量

248

审稿时长

3.5 months

期刊介绍： Luminescence provides a forum for the publication of original scientific papers, short communications, technical notes and reviews on fundamental and applied aspects of all forms of luminescence, including bioluminescence, chemiluminescence, electrochemiluminescence, sonoluminescence, triboluminescence, fluorescence, time-resolved fluorescence and phosphorescence. Luminescence publishes papers on assays and analytical methods, instrumentation, mechanistic and synthetic studies, basic biology and chemistry. Luminescence also publishes details of forthcoming meetings, information on new products, and book reviews. A special feature of the Journal is surveys of the recent literature on selected topics in luminescence.