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通过阻断光致电子转移评估维拉唑酮的新型荧光分光光度法:分析性能及绿色度-蓝色度评估

Novel spectrofluorometric approach for assessing vilazodone by blocking photoinduced electron transfer: analytical performance, and greenness-blueness evaluation.

作者信息

Derayea Sayed M, Elhamdy Hadeer A, Badr El-Din Khalid M, Oraby Mohamed

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Minia University Minia 61519 Egypt

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Sohag University Sohag 82524 Egypt.

出版信息

RSC Adv. 2024 Jan 29;14(6):4065-4073. doi: 10.1039/d3ra08034j. eCollection 2024 Jan 23.

Abstract

In this paper, vilazodone (VLD), a serotonin modulator prescribed for major depressive disorder, was investigated using a rapid, highly sensitive, and eco-friendly spectrofluorometric approach. The native fluorescence of VLD, originating from its indole moiety, exhibited an emission peak at 486 nm upon excitation at 241 nm. However, the presence of a piperazinyl nitrogen atom in the VLD structure, acting as an electron donor, significantly diminished the fluorescence intensity through photoinduced electron transfer (PET) to the indole ring. However, by protonating this nitrogen atom using 0.02 M Teorell-Stenhagen buffer (pH 3.5), inhibition of the PET process effectively blocked electron transfer, restoring the fluorescent properties of the drug. Further, an enhancement in the fluorescence was achieved by employing methanol as the solvent, resulting in a 1.5-fold increase. The combined use of PET blockage and methanol enabled the detection of VLD at levels as low as 0.78 ng mL. Calibration analysis demonstrated linearity within the range 5-400 ng mL, exhibiting a correlation coefficient of 0.9998 and a limit of quantification of 2.37 ng mL. The method obeyed the requirements of International Council on Harmonization (ICH). The proposed approach was applied for the accurate measurement of VLD in pharmaceutical tablets, content uniformity testing based on USP requirements, and determining VLD concentration in spiked human plasma. Moreover, the environmental impact, in addition to practical effectiveness, of the proposed approach was evaluated using different metrics.

摘要

在本文中,使用一种快速、高灵敏度且环保的荧光光谱法对用于治疗重度抑郁症的5-羟色胺调节剂维拉唑酮(VLD)进行了研究。VLD的天然荧光源自其吲哚部分,在241nm激发时在486nm处呈现发射峰。然而,VLD结构中存在的哌嗪基氮原子作为电子供体,通过光诱导电子转移(PET)至吲哚环,显著降低了荧光强度。但是,通过使用0.02M的Teorell-Stenhagen缓冲液(pH 3.5)使该氮原子质子化,PET过程的抑制有效阻断了电子转移,恢复了药物的荧光特性。此外,通过使用甲醇作为溶剂实现了荧光增强,荧光强度增加了1.5倍。PET阻断和甲醇的联合使用能够检测低至0.78 ng/mL水平的VLD。校准分析表明在5 - 400 ng/mL范围内呈线性,相关系数为0.9998,定量限为2.37 ng/mL。该方法符合国际协调理事会(ICH)的要求。所提出的方法用于准确测量药物片剂中的VLD、基于美国药典要求进行含量均匀度测试以及测定加标人血浆中的VLD浓度。此外,使用不同指标评估了所提出方法的环境影响以及实际有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f19/10823494/86a40dd1ae57/d3ra08034j-f1.jpg

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