Mullen John H, Shugert Richard L, Ponsler George D, Li Qimin, Sundaram Bhaskar, Coales Heather L, Yakupkovic Joseph E, Lelacheur Richard M, Wheeler William J, Belas Frank J, Sauer John-Michael
Lilly Research Laboratories, Lilly Corporate Center, Drop Code 0720, Eli Lilly and Company, Indianapolis, IN 46285, USA.
J Pharm Biomed Anal. 2005 Jul 15;38(4):720-33. doi: 10.1016/j.jpba.2005.02.007.
A sensitive and selective liquid chromatography tandem mass spectrometry (LC/MS/MS) method for the determination of atomoxetine and its metabolites (4-hydroxyatomoxetine, N-des-methylatomoxetine, and 4-hydroxyatomoxetine-O-glucuronide) has been developed for human plasma and urine. Using stable-labeled internal standards, the method proved to be accurate and precise for the analytes in all species, resulting in inter-batch accuracy (percent relative error, %RE) within 100+/-13% and inter-batch precision (relative standard deviation, %RSD) within 11%. Stability was demonstrated for the analytes in neat solutions and the reconstitution solvent, as well as plasma and urine (with or without the deconjugation reagent). The method was simple, robust (utilized for the analysis of several hundred clinical study samples), and amenable to high sample throughput.
已开发出一种灵敏且具选择性的液相色谱串联质谱法（LC/MS/MS），用于测定人血浆和尿液中的托莫西汀及其代谢物（4-羟基托莫西汀、N-去甲基托莫西汀和4-羟基托莫西汀-O-葡萄糖醛酸苷）。使用稳定同位素标记的内标，该方法对所有物种中的分析物均准确且精密，批间准确度（相对误差百分比，%RE）在100±13%以内，批间精密度（相对标准偏差，%RSD）在11%以内。在纯溶液、复溶溶剂、血浆和尿液（添加或不添加去共轭试剂）中均证明了分析物的稳定性。该方法简单、稳健（用于数百份临床研究样本的分析），且适用于高通量样本分析。
