Hammad Mohamed A, Omar Mahmoud A, Salman Baher I
Department of Analytical Chemistry, Minia University, Minia, Egypt.
Department of Pharmaceutical Analytical Chemistry, Al-Azhar University, Assiut, Egypt.
Luminescence. 2017 Sep;32(6):1066-1071. doi: 10.1002/bio.3292. Epub 2017 Mar 17.
A highly sensitive, cheap, simple and accurate spectrofluorimetric method has been developed and validated for the determination of alfuzosin hydrochloride and terazosin hydrochloride in their pharmaceutical dosage forms and in human plasma. The developed method is based on the reaction of the primary amine moiety in the studied drugs with acetylacetone and formaldehyde according to the Hantzsch reaction, producing yellow fluorescent products that can be measured spectrofluorimetrically at 480 nm after excitation at 415 nm. Different experimental parameters affecting the development and stability of the reaction products were carefully studied and optimized. The fluorescence-concentration plots of alfuzosin and terazosin were rectilinear over a concentration range of 70-900 ng ml , with quantitation limits 27.1 and 32.2 ng ml for alfuzosin and terazosin, respectively. The proposed method was validated according to ICH guidelines and successfully applied to the analysis of the investigated drugs in dosage forms, content uniformity test and spiked human plasma with high accuracy.
已开发并验证了一种高灵敏度、廉价、简单且准确的荧光分光光度法，用于测定盐酸阿夫唑嗪和盐酸特拉唑嗪的药物剂型及人血浆中的含量。所开发的方法基于所研究药物中的伯胺部分与乙酰丙酮和甲醛按照汉茨希反应进行反应，生成黄色荧光产物，该产物在415nm激发后可于480nm处进行荧光分光光度测定。仔细研究并优化了影响反应产物形成和稳定性的不同实验参数。阿夫唑嗪和特拉唑嗪的荧光-浓度曲线在70 - 900 ng/ml的浓度范围内呈线性，阿夫唑嗪和特拉唑嗪的定量限分别为27.1和32.2 ng/ml。所提出的方法按照国际人用药品注册技术协调会（ICH）指南进行了验证，并成功应用于药物剂型中被研究药物的分析、含量均匀度测试以及加标人血浆的分析，具有很高的准确度。
