今日药学

2021, v.31(01) 46-49

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HPLC-MS/MS法测定人血清中奋乃静浓度及其临床应用
Determination the Concentration of Perphenazine in Human Serum by HPLC-MS/MS and Its Clinical Application

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;
TAN Yaqian;LU Haoyang;SHANG Dewei;WANG Zhanzhang;NI Xiaojia;ZHANG Ming;DENG Shuhua;ZHU Xiuqing;HU Jinqing;WEN Yuguan;The Affiliated Brain Hospital of Guangzhou Medical University;

摘要(Abstract):

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,1.8μm);流动相为甲醇-水(90∶10,V/V,2 mmol·L-1甲酸铵);流速为0.7 m L·min-1;柱温35℃;进样量10μL。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·m L-1。定量下限(0.10 ng·m L-1),低(0.30 ng·m L-1),中(3.00 ng·m L-1),高(7.50 ng·m L-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. CONCLUSION 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 m L·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 = 2.014 X-0.012 8( R2= 0.998 6) within the linear ranges of 0.10-10.00 ng·m L-1. In the four concentrations of quality control sample of LLOQ( 0.10 ng·m L-1),LQC( 0.30 ng·m L-1),MQC( 3.00 ng·m L-1) and HQC( 7.50 ng·m L-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.

关键词(KeyWords): 奋乃静;高效液相色谱串联质谱法;治疗药物监测
perphenazine;HPLC-MS/MS;therapeutic drug monitoring

Abstract:

Keywords:

基金项目(Foundation): 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(Author): 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;
TAN Yaqian;LU Haoyang;SHANG Dewei;WANG Zhanzhang;NI Xiaojia;ZHANG Ming;DENG Shuhua;ZHU Xiuqing;HU Jinqing;WEN Yuguan;The Affiliated Brain Hospital of Guangzhou Medical University;

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