Apostolou Constantinos, Dotsikas Yannis, Kousoulos Constantinos, Tsatsou Georgia, Colocouri Filomila, Soumelas Georgios-Stefanos, Loukas Yannis L
Laboratory of Pharmaceutical Analysis and Bioequivalence Services (GLP Compliant), Department of Pharmaceutical Chemistry, School of Pharmacy, University of Athens, Panepistimioupoli Zografou, GR 15771 Athens, Greece.
J Pharm Biomed Anal. 2007 Feb 19;43(3):1151-5. doi: 10.1016/j.jpba.2006.09.012. Epub 2006 Oct 11.
In the current study, a semi-automated, 96-well format, solid-phase extraction (SPE), analytical column-switching method for alendronate determination in human urine is developed, validated and applied to a bioequivalence study. The current protocol was a substantial improvement of an existing classical method. A robotic liquid handling system was employed to simplify and reduce the time of sample preparation procedure. Automated SPE was carried out using a 96-well cartridge plate and a vacuum control system. Urine samples were determined by applying a column-switching protocol with fluorescence detection. Analysis time, due to the column-switching procedure, was about half of the conventional LC approach (11.5 min instead of 21 min). The method application required the determination of alendronate in urine samples obtained from 96 healthy volunteers as part of a bioequivalence study of two 70 mg alendronate sodium tablets. All major pharmacokinetic parameters of the bioequivalence study were estimated and reported.
在本研究中，开发、验证了一种用于测定人尿中阿仑膦酸盐的半自动、96孔板、固相萃取（SPE）、分析柱切换方法，并将其应用于生物等效性研究。当前方案是对现有经典方法的重大改进。采用机器人液体处理系统简化并缩短了样品制备过程的时间。使用96孔柱板和真空控制系统进行自动固相萃取。通过应用柱切换方案和荧光检测来测定尿样。由于柱切换程序，分析时间约为传统液相色谱方法的一半（11.5分钟而非21分钟）。作为两种70毫克阿仑膦酸钠片剂生物等效性研究的一部分，该方法应用需要测定从96名健康志愿者获得的尿样中的阿仑膦酸盐。估算并报告了生物等效性研究的所有主要药代动力学参数。
