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1、#386#HeraldofMedicineVol127No14April2008高效液相色谱法测定人血浆中氯氮平浓度12333吴岚,朱军,刘文宪,刘伟忠,王华成(1.湖南省血防所附属湘岳医院药剂科,岳阳414000;2.中山大学附属第二医院药学部,广州510120;3.广州市脑科医院国家药品临床研究基地,广州510370)TM[摘要]目的建立测定人血浆中氯氮平浓度的高效液相色谱法。方法以DiamonsilC18反相柱(150mm@-1-14.6mm,5Lm)为色谱柱,流动相为0.03mol#L醋酸铵-
2、甲醇(25z75);流速0.8mL#min,柱温40e,检测波长254-1nm。以醋酸乙酯与二氯甲烷(80z20)为提取剂。结果氯氮平的高、中、低(1000.0,400.0,10.0ng#mL)3种浓度平均回收率分别为98.28%,97.63%,101.41%,日内、日间精密度RSD均<7%(n=5);分析方法的检测限为5.0-1-1ng#mL;线性范围为10.0~1000.0ng#mL。曲线方程:C=25.69F+3.47,r=0.9997(n=10)。结论该方法灵敏、准确、简单、快速,可用于临床血
3、药浓度监测和药动学研究。[关键词]氯氮平;血药浓度;色谱法,高效液相[中图分类号]R971.4;R927.2[文献标识码]A[文章编号]1004-0781(2008)04-0386-03ConcentrationsDeterminationofClozapineinHumanPlasmabyHPLC12333WULan,ZHUJun,LIUWen-xian,LIUWe-izhong,WANGHua-cheng(1.DepartmentofPharmacy,XiangyueHospitalAffliat
4、edwithHunanInstiluteofParsitic,Yueyang414000,China;2.DepartmentofPharmacy,theSecondAffiliatedHospital,SunYat-senUniversity,Guangzhou510120,China;3.BaseofDrugClinicalStudyofGuangzhouBrainHospital,Guangzhou510370,China)ABSTRACTObjectiveToestablishamethodf
5、ordeterminingtheconcentrationofclozapineinhumanplasmabyHPLC.MethodsThedrugfromplasmawasanalyzedinareversephaseHPLCsystemC18column(150mm@4.6mm,5-1-1Lm);mobilephaseconsistedof0.03mol#Lammonioum-methanol(25z75);theflowratewas0.8mL#min;thedetectionwavelengt
6、hwasat254nm.Ethylacetateanddichloromethane(80z20)wasusedasextractingsolvent.ResultsTheaverage-1recoveriesofclozapineinhigh,middleandlowconcentrations(1000.0,400.0,10.0ng#mL)were98.28%,97.63%and101.41%,respectively.Theintra-dayandinter-dayvariation(RSD)w
7、aslessthan7%(n=5).Thecalibrationcurveof-1clozapineshowedgoodlinearity,r=0.9997(n=10),overtherangeof10.0-1000.0ng#mL.Theregressionequationwas-1C=25.69F+3.47,r=0.9997(n=10).Theminimumdetectableconcentrationofclozapinewas5.0ng#mL.ConclusionThemethodissensi
8、tive,accurate,easyandquick,whichcanbeusedforclinicaldrugmonitoringandpharmacokineticsstudies.KEYWORDSClozapine;Plasmaconcentration;HPLC氯氮平是一种非经典抗精神病药物,对精神病阳单、快速测定人血浆中氯氮平浓度的高效液相色谱法。性和阴性症状均有良好的疗效,较少引起锥体外系反1仪器与材料[1]应(EPS)。但氯氮平可引起粒细胞