开发和验证利用流动注射分析法测量维拉唑酮的新型荧光测定法:在剂型和加标人体血浆中的应用

IF 4.3 2区 化学 Q2 CHEMISTRY, MULTIDISCIPLINARY
Al Amir S. Zaafan, Sayed M. Derayea, Mohamed Oraby, Dalia M. Nagy
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引用次数: 0

摘要

采用直接、精确、快速、简便的流动注射法测定了制剂和生物液中盐酸维拉唑酮的含量。VZN有一个吲哚环作为其结构的一部分,这使它具有显著的天然荧光。本研究的基础是测定VZN的强本征荧光,在241 nm激发后在486 nm处测量。磷酸缓冲液(pH 5, 10 mM):乙腈(40:60,v/v)为载体溶液,流速0.5 mL min - 1。基于峰面积,VZN在10 ~ 300 ng mL−1浓度范围内呈线性关系,相关系数(r)为0.9999。定量限为9.62 ng mL−1,检出限为3.17 ng mL−1。该方法可准确测定其片剂剂型中的VZN含量。此外,所研究的药物也令人满意地测量在血液中使用建议的流动注射方法。根据ICH规范对该方法进行了验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and validation of a novel fluorometric approach utilizing flow injection analysis for the measurement of vilazodone: application to dosage form and spiked human plasma

A direct, precise, rapid and simple flow injection approach has been applied to determine vilazodone HCl (VZN) in pharmaceutical dosage forms and biological fluids. VZN has an indole ring as part of its structure, which gives it a significant native fluorescence. The study was based on determining the strong intrinsic fluorescence of VZN, which was measured at 486 nm after excitation at 241 nm. Phosphate buffer (pH 5, 10 mM): Acetonitrile (40:60, v/v) was utilized as the carrier solution, with a flow rate of 0.5 mL min− 1. Based on peak area, the calibration graph was linear over a concentration range of 10–300 ng mL− 1 of VZN with a correlation coefficient (r) of 0.9999. The quantitation limit was 9.62 ng mL− 1, while the detection limit was 3.17 ng mL− 1. Moreover, the suggested method was used to accurately measure VZN in its tablet dosage form. Additionally, the studied drug was also satisfactorily measured in blood using the suggested flow injection methodology. The approach was validated according to ICH specifications.

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来源期刊
BMC Chemistry
BMC Chemistry Chemistry-General Chemistry
CiteScore
5.30
自引率
2.20%
发文量
92
审稿时长
27 weeks
期刊介绍: BMC Chemistry, formerly known as Chemistry Central Journal, is now part of the BMC series journals family. Chemistry Central Journal has served the chemistry community as a trusted open access resource for more than 10 years – and we are delighted to announce the next step on its journey. In January 2019 the journal has been renamed BMC Chemistry and now strengthens the BMC series footprint in the physical sciences by publishing quality articles and by pushing the boundaries of open chemistry.
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