Spectacular Application of Isoindole-Based Fluorophore for Mirabegron Assay in Tablets and Biological Fluids (Urine/Plasma). Assessment of Method Blueness and Whiteness

IF 3.2 4区 化学 Q2 CHEMISTRY, ANALYTICAL
Luminescence Pub Date : 2025-02-10 DOI:10.1002/bio.70120
Ahmed A. Abu-hassan, Wael A. Mahdi, Sultan Alshehri, Bandar R. Alsehli, Safaa F. Saleh, Mohamed A. El Hamd
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引用次数: 0

Abstract

The FDA has approved mirabegron (MBG) for alleviating urgency in micturition and incontinence. Its mechanism of action involves the activation of β3-adrenoreceptors. The present research outlines a novel, highly sensitive, and cost-effective protocol for analyzing MBG. The current research relies on MBG interaction with o-phthalaldehyde alongside 2-mercaptoethanol. The resulting isoindole fluorophore was quantified at λex 337.7 and λem 433.7 nm. A comprehensive analysis was conducted to systematically examine and enhance the several experimental factors that impact the creation of the isoindole-based fluorophore outcome. A linear correlation was established by precisely manipulating these variables, demonstrating that the increase in fluorescence strength is directly correlated to the quantity of MBG within the range of 30 to 1000 ng/mL. The analytical method was able to reliably detect MBG concentrations as low as 9 ng/mL and accurately quantify levels down to 27.5 ng/mL. This analytical procedure was effectively employed to determine the concentration of MBG in commercially available tablet formulations, as well as in plasma/urine samples. Furthermore, the strategy was extended to assess the content uniformity of MBG-containing products, providing results with satisfactory accuracy and precision. Importantly, this approach is cost-effective, environmentally friendly, and can be readily implemented for quality control and routine monitoring of MBG in pharmaceutical products. The suggested approach was evaluated utilizing the RGB12 and BAGI tools. The outcomes abundantly show the practicability and integrity of the planned strategy.

基于异吲哚的荧光团在Mirabegron片和生物液体(尿液/血浆)测定中的惊人应用。方法评定蓝白度
FDA已批准mirabegron (MBG)用于缓解尿急和尿失禁。其作用机制涉及β3-肾上腺素受体的激活。本研究概述了一种分析MBG的新颖、高灵敏度和高成本效益的方案。目前的研究依赖于MBG与邻苯二醛和2-巯基乙醇的相互作用。所得异吲哚荧光团在λex 337.7和λem 433.7 nm处定量。进行了全面的分析,以系统地检查和加强影响产生基于异吲哚的荧光团结果的几个实验因素。通过精确处理这些变量,建立了线性相关关系,表明荧光强度的增加与30 ~ 1000 ng/mL范围内MBG的量直接相关。该分析方法能够可靠地检测低至9 ng/mL的MBG浓度,并准确量化低至27.5 ng/mL的水平。本分析方法可有效测定市售片剂及血浆/尿液样品中MBG的浓度。此外,将该策略扩展到含mbg产品的含量均匀性评估,结果具有令人满意的准确度和精密度。重要的是,这种方法具有成本效益,环境友好,并且可以很容易地用于药品中MBG的质量控制和常规监测。采用RGB12和BAGI工具对建议的方法进行评估。结果充分显示了规划策略的实用性和完整性。
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来源期刊
Luminescence
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.
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