Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, Turkey.
Luminescence. 2012 Nov-Dec;27(6):489-94. doi: 10.1002/bio.1381. Epub 2012 Jan 30.
A new, simple and sensitive spectrofluorimetric method has been developed for the determination of aliskiren (ALS) in dosage forms and human urine. The method is based on the reaction between ALS and fluorescamine in borate buffer solution, pH 9, to give a highly fluorescent derivative which is measured at 482 nm after excitation at 382 nm. The factors affecting the reaction were carefully studied. The fluorescence intensity concentration plots were rectilinear over the range 140-1400 ng/mL with a limit of detection 13.47 ng/mL and limit of quantitation 40.81 ng/mL. The developed method was successfully applied to the analysis of the drug in tablets and human urine; the average recoveries (n = 6) were 99.88 ± 0.38% and 99.57 ± 0.44%, respectively. The analytical performance of the method was fully validated and the results were satisfactory. The stability of the drug was studied by subjecting it to acidic, basic, oxidative and thermal degradation.
一种新的、简单而灵敏的荧光分光光度法已经被开发出来，用于测定药物制剂和人尿中的阿利克仑（ALS）。该方法基于 ALS 在硼酸缓冲溶液（pH 9）中与荧光胺的反应，生成一种高荧光衍生物，在 382nm 激发下，于 482nm 处测量其荧光强度。仔细研究了影响反应的因素。在 140-1400ng/mL 范围内，荧光强度浓度图呈线性关系，检测限为 13.47ng/mL，定量限为 40.81ng/mL。该方法成功地应用于片剂和人尿中药物的分析；平均回收率（n=6）分别为 99.88±0.38%和 99.57±0.44%。该方法的分析性能得到了充分验证，结果令人满意。通过对药物进行酸、碱、氧化和热降解研究，考察了药物的稳定性。
