Department of Pharmacy, Xiamen Xianyue Hospital.
Fujian Provincial Key Laboratory of Innovative Drug Target Research and State Key Laboratory of Cell Stress Biology, School of Pharmaceutical Sciences, Xiamen University.
Ther Drug Monit. 2021 Aug 1;43(4):577-588. doi: 10.1097/FTD.0000000000000839.
A comprehensive, stable, and efficient high-performance liquid chromatography-tandem mass spectrometry method was developed for rapidly analyzing 14 antidepressants and 13 antipsychotics in human plasma for routine clinical therapeutic drug monitoring.
Simple protein precipitation was used for the pretreatment of plasma samples; dynamic multiple reaction monitoring was used to avoid the loss of sensitivity caused by numerous ion transitions. In all, 80 ion transitions of 40 compounds were quantitatively determined in 6 minutes.
The limit of detection for the 27 analytes was in the range of 0.1-30 ng/mL, and all calibration lines prepared using blank plasma were linear with a correlation coefficient of r2 ≥ 0.99. The method was accurate and precise with acceptable intraday and interday precisions (coefficients of variation, ≤20% for a lower limit of quantification and ≤15% for other quality control samples) and an accuracy of 85.51%-114.77%. This analysis method has been completely validated and successfully used in routine clinical therapeutic drug monitoring for more than 9963 samples [including 488 samples having drug concentrations above the laboratory alert level (supra-alert-level samples)] at Xiamen Xianyue Hospital.
This dynamic method is comprehensive (includes most antidepressants and antipsychotics listed in China), reliable (stably used for almost 2 years), and efficient (convenient sample processing and short run time) and provides a large amount of meaningful data for optimized pharmacotherapy. Our experimental data from the plasma concentrations of supra-alert-level samples could serve as a reference for the interpretation of the pharmacokinetics of patients with a high risk of toxicity or loss of tolerability.
建立了一种灵敏、稳定、高效的测定人血浆中 14 种抗抑郁药和 13 种抗精神病药的超高效液相色谱-串联质谱法,用于常规临床治疗药物监测。
采用简单的蛋白沉淀法进行血浆样品预处理;采用动态多反应监测,避免了因离子转换过多而导致的灵敏度损失。总共在 6 分钟内定量测定了 40 种化合物的 80 个离子转换。
27 种分析物的检测限在 0.1-30ng/ml 之间,使用空白血浆制备的所有校准曲线均呈线性,相关系数 r2≥0.99。该方法准确、精密,日内和日间精密度(变异系数,定量下限的≤20%和其他质控样品的≤15%)和准确度(85.51%-114.77%)均可接受。该分析方法已完全验证,并已成功用于厦门仙岳医院 9963 多个常规临床治疗药物监测样本[包括 488 个药物浓度高于实验室警戒水平(超警戒水平样本)]。
该动态方法全面(包括中国列出的大多数抗抑郁药和抗精神病药)、可靠(近 2 年来稳定使用)、高效(方便的样品处理和短运行时间),为优化药物治疗提供了大量有意义的数据。我们从超警戒水平样本的血浆浓度中获得的实验数据可作为解释毒性或不耐受风险高的患者药代动力学的参考。