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  

Determination of Concentration of Paroxetine and Clozapine in Human Plasma by HPLC with UV Detection

作　　者：刘伟忠[1] 陈清霞[2] 黄伟侨[3] 温预关[1] 

机构地区：[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

出　　处：《今日药学》2013年第1期36-39,共4页Pharmacy Today

基　　金：广东省自然科学基金资助项目(编号:8151037001000001)

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,5μm)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10.0～640.0μg/L、氯氮平在25.0～1 000.0μg/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5.0μg/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 txg/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.

关 键 词：帕罗西汀 氯氮平 血药浓度 高效液相色谱法 

分 类 号：R969[医药卫生—药理学]