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一种利用流动注射分析测定维拉唑酮的新型荧光法的开发与验证:在剂型和加标人血浆中的应用

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.

作者信息

Zaafan Al Amir S, Derayea Sayed M, Oraby Mohamed, Nagy Dalia M

机构信息

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

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

出版信息

BMC Chem. 2025 Apr 13;19(1):96. doi: 10.1186/s13065-025-01458-6.

Abstract

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. Based on peak area, the calibration graph was linear over a concentration range of 10-300 ng mL of VZN with a correlation coefficient (r) of 0.9999. The quantitation limit was 9.62 ng mL, while the detection limit was 3.17 ng mL. 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.

摘要

一种直接、精确、快速且简单的流动注射方法已被应用于测定药物剂型和生物流体中的盐酸维拉唑酮(VZN)。VZN的结构中含有一个吲哚环,这使其具有显著的天然荧光。该研究基于测定VZN的强固有荧光,在241nm激发后于486nm处进行测量。磷酸盐缓冲液(pH 5,10 mM):乙腈(40:60,v/v)用作载液,流速为0.5 mL/min。基于峰面积,校准曲线在10 - 300 ng/mL的VZN浓度范围内呈线性,相关系数(r)为0.9999。定量限为9.62 ng/mL,检测限为3.17 ng/mL。此外,所建议的方法用于准确测定其片剂剂型中的VZN。另外,使用所建议的流动注射方法在血液中对所研究药物的测量也令人满意。该方法根据ICH规范进行了验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cfd5/11995563/cb93de5db4e3/13065_2025_1458_Fig1_HTML.jpg

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