中国临床药学杂志2017，Vol.26Issue(4)：217-221,5.
LC-MS/MS法检测人血清中阿米卡星浓度及临床应用
A liquid chromatography-tandem mass spectrometry method for the determination of amikacin in human serum and its clinical application
彭小林 1范亚新 2张亮 3李熠 4郁继诚 3郭蓓宁 3陈代杰 3张菁 2武晓捷3
作者信息
- 1. 上海师范大学生命与环境科学学院,上海 200234
- 2. 中国医药工业研究总院上海医药工业研究院,上海 200040
- 3. 复旦大学附属华山医院抗生素研究所,上海 200040
- 4. 复旦大学附属华山医院药剂科,上海 200040
- 折叠
摘要
Abstract
AIM To establish a rapid,accurate liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of amikacin in human serum and apply this method to analyze the clinical samples.METHODS Serum samples were spiked with kanamycin (internal standard,IS),pretreated by protein precipitation with 0.1％ formic acid in methanol-acetonitrile (2∶1) and then diluted for injection.The compounds were separated by Atlantis(R) Hilic Silica column (50 mm × 2.1 mm,3.0 μm).The detection was performed in selected reaction monitoring mode at ion transition of m/z 586.3→163.0 for amikacin and m/z 485.2→163.0 for IS.After methodology validation,this method was applied for the clinical analysis of amikacin in serum specimens from patients.RESULTS The calibration curve was linear over the range from 0.50 mg · L-1 to 100.00 mg ·L-1,with a correlation coefficient (R2) of 0.993 8.The intra-and inter-batch precision (coefficient of variation)was less than 15.0％,the accuracy ranged from 92.6％ to 105.9％.The internal standard normalized matrix effect ranged from 91.2％ to 101.2％,coefficient of variation was less than 15.0％.The values of extraction recovery were from 92.6％ to 105.9％ for amikacin and 78.1％ for IS.The samples were stored stably as follows:56 days at 4℃,86 days at-70℃,21 days at 35℃ and room temperature.Thirty-four trough concentration serum samples were collected from 19 patients,the concentrations of 16 samples were under lower limit of quantification,while the others were between 0.52 mg· L-1 and 19.12 mg · L-1.CONCLUSION The method is simple,accurate and suitable for the determination of amikacin in human serum.A significant difference among concentrations of trough samples suggests that it's necessary to conduct therapeutic drug monitoring when using amikacin in the clinics.关键词
阿米卡星/LC-MS/MS/血清浓度/治疗药物浓度监测Key words
amikacin/LC-MS/MS/serum concentration/therapeutic drug monitoring引用本文复制引用
彭小林,范亚新,张亮,李熠,郁继诚,郭蓓宁,陈代杰,张菁,武晓捷..LC-MS/MS法检测人血清中阿米卡星浓度及临床应用[J].中国临床药学杂志,2017,26(4):217-221,5.
