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高效液相色谱法同时测定人血浆中帕罗西汀与氯氮平浓度
作者:刘伟忠1 陈清霞2 黄伟侨3 温预关1 
单位:1. 广州市脑科医院国家药品临床研究基地,广东广州510370; 2. 中山大学附属第二医院药学部,广东广州510120;3. 中山大学附属第一医院药学部,广东广州510080
关键词:帕罗西汀 氯氮平 血药浓度 高效液相色谱法 
中图分类号:R969
文献标志码:A
出版年,卷(期):页码:2013,23(1):36-39,
收稿日期:2012 -11 -05
摘要:
目的建立同时测定人血浆中帕罗西汀、氯氮平浓度的高效液相色谱法。方法以Diamonsil C18 反相柱(150 mm ×4. 6 mm,5 μm)为色谱柱,流动相为30 mmol/ L 醋酸铵- 甲醇(25∶75);流速:1. 0 mL/ min;柱温:40 ℃; 检测波长:265 nm。以乙酸乙酯- 二氯甲烷(80∶20)为提取剂。结果帕罗西汀在10. 0 ~640. 0 μg/ L、氯氮平在25. 0 ~1 000. 0 μg/ L 浓度范围内,峰面积与其浓度呈良好线性关系;帕罗西汀、氯氮平的低、中、高3 种浓度相对平均回收率大于95%,提取回收率大于70%。日内、日间RSD 均低于15%(n =5);分析方法的检测限5. 0 μg/ L。帕罗西汀线性方程: Y =23. 325X +2. 78,r = 0. 998 2(n = 7);氯氮平线性方程: Y = 28. 651X + 1. 82,r =0.998 6(n =7)。结论该方法灵敏、准确、简单、快速,可用于临床帕罗西汀与氯氮平血药浓度监测和药动学研究。
Objective To establish a method for determining the concentration of paroxetine and clozapine in human
plasma by HPLC. Methods The drugs from plasma was analyzed in a reverse phase HPLC system C18 column(150 mm ×4.6 mm, 5 μm); mobile phase consisted of 30 mmol/ L ammonioum-acetonitrile (25∶75); the flow rate was 1.0 mL/ min;the detection wavelength was at 265 nm. Ethyl acetate and dichloromethane (80∶20) was used as extracting solvent.Results The calibration curves were linear in the range of 10. 0 -640. 0 μg/ L for paroxetine, 25. 0 -1 000. 0 μg/ L for clozapine respectively. The average recoveries of paroxetine and clozapine in low, middle and high concentrations over 95% respectively; the extraction recovery over 70% respectively. The intra-day and inter-day variation (RSD) was less than 15% (n = 5). The minimum detectable concentration of paroxetine and clozapine was 5. 0 μg/ L. The calibration curve of paroxetine and clozapine showed good linearity, r =0. 998 2 and r =0. 998 6 (n =7) respectively. The regression equation of paroxetine was Y =23. 325X +2. 78 and clozapine was Y =28. 651X +1. 82,respectively. Conclusion:The method is sensitive, accurate, simple and quick, it can be used for clinical drug monitoring and pharmacokinetics studies of paroxetine and clozapine.
基金项目:
广东省自然科学基金资助项目(编号:8151037001000001)
作者简介:
刘伟忠,副主任药师,从事临床药学工作,Tel:020 -81268052,E-mail: liuweizhong999@163. com
通讯作者:温预关,主任药师,研究方向: 临床药理学,Tel:020 -81268052,E-mail: wenyuguande@163. com
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