Prominently selective fluorescence approach with distinctive biopharmaceutical utility for analysis of lurasidone in human plasma and urine: Application to in vitro dissolution and content uniformity testing

IF 3.2 4区 化学 Q2 CHEMISTRY, ANALYTICAL
Luminescence Pub Date : 2024-09-06 DOI:10.1002/bio.4887
Yasmeen E. Mostafa, Mohammed El-Sayed Metwally, Fawzi Elsebaei
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引用次数: 0

Abstract

A relevant approach based on the attractive inherited merits of fluorescence spectroscopy has been established for quantitative estimation of a newly approved second-generation atypical antipsychotic lurasidone (LUR) in its raw materials and pharmaceutical dosage forms. This study brings to light the strong native fluorescence of LUR at 400 nm in water after excitation at 316 nm. Different experimental parameters that may compromise the fluorescence of the drug were carefully investigated and optimized. A linear response was established between the relative fluorescence intensity and concentration over the concentration range of 50–650 ng/mL with excellent correlation (r = 0.9998). The validity of the method was evidenced in accordance with International Council for Harmonization guidelines, with minimal detection and quantification limits of 2.88 and 8.73 ng/mL, respectively. The method was effectively applied for the estimation of LUR in spiked human plasma and urine samples with acceptable recoveries. The biopharmaceutical significance of the method was heightened by its successful applications for both content uniformity and in vitro dissolution testing. Three different tools accredited the greenness character of the presented study. Eco-friendliness, effortlessness, and cost effectiveness are crucial hallmarks of our study. The presented study demonstrates potential applicability in quality control laboratories with limited resources.

Abstract Image

用于分析人血浆和尿液中鲁拉西酮的具有显著生物制药用途的选择性荧光方法:应用于体外溶出度和含量均匀性测试。
荧光光谱法具有诱人的固有优点,基于此建立了一种相关方法,用于定量估算新批准的第二代非典型抗精神病药物鲁拉西酮(LUR)在其原料和药物剂型中的含量。这项研究揭示了 LUR 在 316 纳米波长激发后在水中 400 纳米波长处发出的强烈本征荧光。对可能影响药物荧光的不同实验参数进行了仔细研究和优化。在 50-650 ng/mL 的浓度范围内,相对荧光强度与浓度之间呈线性响应,相关性极佳(r = 0.9998)。该方法的最低检出限为 2.88 ng/mL,最低定量限为 8.73 ng/mL,符合国际协调理事会的准则。该方法有效地测定了加标人体血浆和尿液样品中的LUR,回收率可接受。该方法成功应用于含量均一性和体外溶出度测试,提高了其生物制药意义。三种不同的工具证明了本研究的绿色特性。环保、简便和成本效益是我们研究的重要标志。这项研究表明,它在资源有限的质量控制实验室中具有潜在的适用性。
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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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