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公告栏:
HPLC-MS/MS法测定人血清中奋乃静浓度及其临床应用
作者:谭亚倩  卢浩扬  尚德为  王占璋  倪晓佳  张明  邓书华  朱秀清  胡晋卿  温预关 
单位:广州医科大学附属脑科医院, 广东 广州 510370
关键词:奋乃静 高效液相色谱串联质谱法 治疗药物监测 
中图分类号:R917
文献标志码:
出版年,卷(期):页码:2021,31(1):46-49,
收稿日期:2020-4-26
摘要:
目的 采用高效液相色谱串联质谱法(HPLC-MS/MS)建立测定人血清中奋乃静浓度的方法。方法 色谱条件:色谱柱为Aglient XDB-C18(4.6 mm×50 mm,1.8 μm);流动相为甲醇-水(90:10,V/V,2 mmol·L-1甲酸铵);流速为0.7 mL·min-1;柱温35℃;进样量10 μL。采用乙腈蛋白沉淀法前处理血清样本,定量离子对分别为m/z 404.15→m/z 171.15(奋乃静)和m/z 412.15→m/z 179.15(奋乃静-d8)。采用该方法对52例233份精神分裂症患者多次口服奋乃静后稳态药物浓度进行监测。结果 奋乃静标准曲线方程为Y=2.014X-0.012 8(R2=0.998 6),线性范围为0.10~10.00 ng·mL-1。定量下限(0.10 ng·mL-1),低(0.30 ng·mL-1),中(3.00 ng·mL-1),高(7.50 ng·mL-1)4个浓度的质控样品的批内和批间精密度RSD<15%,提取回收率分别为101.11%,95.37%,96.52%,101.32%。结论 使用HPLC-MS/MS法检测奋乃静的血药浓度具有灵敏度高、可操作性强、结果准确度高等优点,可用于临床上奋乃静的血药浓度监测。
OBJECTIVE To develop a new method by HPLC-MS/MS for determination the concentration of perphenazine in human serum. METHODS The concentration of perphenazine were measured by HPLC-MS/MS with a analytical column of Aglient XDB-C18(4.6 mm×50 mm, 1.8 μm),The mobile phase were consisted of the methanol and water(90:10, V/V, plus 2 mmol·L-1 ammonium formate). The flow rate was 0.7 mL·min-1. The column temperature was set at 35℃.And the injection volume was 10 μL. The serum specimens were treated by protein precipitation with acetonitrile. The ion transitions were m/z 404.15→m/z 171.15(perphenazine)and m/z 412.15→m/z 179.15(perphenazine-d8), respectively.Perphenazine concentrations of 233 human serum colleted from 52 schizophrenia patients were measured by this method. RESULTS The standard curve of perphenazine was Y=2.014X-0.012 8(R2=0.998 6)within the linear ranges of 0.10-10.00 ng·mL-1. In the four concentrations of quality control sample of LLOQ(0.10 ng·mL-1),LQC(0.30 ng·mL-1),MQC(3.00 ng·mL-1)and HQC(7.50 ng·mL-1), the intra-and inter-assay precisions were lower than 15% and the recoveries were 101.11%,95.37%, 96.52% and 101.32%, respectively. CONCLUSION The method ofdetermination perphenazine by HPLC-MS/MS is sensitive, applicable and precise, which is suitable for the therapeutic drug monitoring(TDM)for patients with perphenazine.
基金项目:
广东省自然科学基金资助项目(2018A0303130074);广州市卫生和计划生育科技项目(20191A011043);广州市荔湾区科技计划(201804017);广州市中医药和中西医结合科技项目(20202A011016);广州市卫生健康科技项目(20201A011047)
作者简介:
谭亚倩,主管药师,研究方向:临床药学
通讯作者:温预关,主任药师,研究方向:临床药物代谢动力学,E-mail:wenyuguande@163.com
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