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一种测定赖诺普利中氢氯噻嗪的创新性、经验证的分光荧光光度法;应用于含量均匀度检测。

An innovative validated spectrofluorimetric method for determination of Lisinopril in presence of hydrochlorothiazide; application to content uniformity testing.

机构信息

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

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

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2018 Jan 5;188:318-323. doi: 10.1016/j.saa.2017.07.021. Epub 2017 Jul 17.

DOI:10.1016/j.saa.2017.07.021
PMID:28750308
Abstract

A new sensitive and discriminating spectrofluorimetric method has been developed and validated for determination of Lisinopril, one of the angiotensin converting enzyme inhibitors, in its pure bulk form and pharmaceutical tablets. The reaction of Lisinopril with ethylacetoacetate and formaldehyde in acidic buffered medium (pH3.8) has yielded a pale yellow product that exhibited a high fluorescence measured at 438nm after excitation at 350nm. All the experimental parameters affecting the formation and stability of the produced fluorophore were carefully investigated and optimized to give the maximum sensitivity. The fluorescence intensity was directly proportional to the drug concentration in the range of 0.5-4.5μg/mL with a limit of detection equal to 0.16μg/mL. The method was successfully applied in the analysis of the commercially available pharmaceutical tablets containing the single drug or its binary mixtures with Hydrochlorothiazide. Furthermore, the developed procedure was adapted for studying the content uniformity test of some dosage forms containing the cited drug.

摘要

已开发并验证了一种新的灵敏且有区别的荧光分光光度法,用于测定血管紧张素转换酶抑制剂中的依那普利(Lisinopril)纯品和片剂中的依那普利。依那普利在酸性缓冲介质(pH3.8)中与乙酰乙酸乙酯和甲醛反应生成浅黄色产物,在 350nm 激发下于 438nm 处测量时显示出高荧光。仔细研究并优化了所有影响荧光团形成和稳定性的实验参数,以获得最大灵敏度。荧光强度与药物浓度在 0.5-4.5μg/mL 范围内呈正比,检测限等于 0.16μg/mL。该方法成功应用于分析含有单药或与氢氯噻嗪的二元混合物的市售片剂。此外,还对一些含有该药物的制剂的含量均匀度试验进行了适应性研究。

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引用本文的文献

1
Switch on fluorescence probe for the selective determination of lisinopril in pharmaceutical formulations: application to content uniformity testing.开启用于药物制剂中赖诺普利选择性测定的荧光探针:在含量均匀度测试中的应用。
RSC Adv. 2018 May 1;8(29):16269-16277. doi: 10.1039/c8ra01617h. eCollection 2018 Apr 27.