人血浆中氯吡格雷及羧酸氯吡格雷浓度检测的意义  

The significance of detection of clopidogrel and clopidogrel carboxylic acid in human plasma by RP-HPLC

作　　者：袁孔现[1] 詹三华[1] 范洁[1] 王秀[1] YUAN Kongxian;ZHAN Sanhua;FAN Jie(Department of Pharmacy,People’s Hospital of Tongling City,Anhui,Tongling 244000,China)

机构地区：[1]安徽省铜陵市人民医院药学部,244000

出　　处：《河北医药》2020年第7期1098-1101,共4页Hebei Medical Journal

摘　　要：目的建立测定人血浆中氯吡格雷及羧酸氯吡格雷浓度的方法,便于临床药物浓度监测和指导临床合理用药。方法使用反相高效液相色谱法(RP-HPLC),以艾司唑仑为内标,采用KromasilTM 100A C18色谱柱(150 mm LD×4.6 mm ID,5μm),流动相为10 mmol/L KH2PO4溶液(含0.25%H3PO4)-乙腈(50∶50),流速为1.0 ml/min,检测波长为220 nm,柱温40℃。结果羧酸氯吡格雷保留时间为1.8 min,标准曲线线性范围为0.12~3.84 mg/L,r=0.9984;氯吡格雷保留时间为7.4 min,标准曲线线性范围为0.11~3.52 mg/L,r=0.9994。氯吡格雷及羧酸氯吡格雷的高、中、低日间、日内变异系数均<15%,提取回收率>85%。结论检测方法简便快捷,重现性良好,准确度及灵敏度符合要求,可用于人血浆中氯吡格雷及羧酸氯吡格雷浓度的监测。Objective To investigate the method for the detection of clopidogrel and clopidogrel carboxylic acid in human plasma by RP-HPLC for therapeutics drug monitoring and rational administration in clinical practice.Methods The RP-HPLC method was used,and estazolam was taken as internal standard,with KromasilTM 100A C18 column at the standard of 150mm LD×4.6mm ID,φ5μm,10mmol/L KH2PO4/H2O(containing 0.25%H3PO4)-CH3CN(50∶50)was taken as mobile phase.The flow rate was 1.0ml/min,and UV detection wave length was 220nm,with the column temperature being 40℃.Results The retention time of clopidogrel carboxylic acid was 1.8min,the linearity range of standard curve was between 0.12~3.84mg/L.The retention time of clopidogrel was 7.4min,and the linearity range of standard curve was between 0.11~3.52mg/L.The coefficient of variation of clopidogrel and clopidogrel carboxylic acid in the high,middle,low concentration in daytime and within the day was less than 15%,and the average recovery rate was more than 85%.Conclusion The detection method(RP-HPLC)is simple,fast and accurate in monitoring the concentration of clopidogrel and clopidogrel carboxylic acid in human plasma.

关 键 词：氯吡格雷 羧酸氯吡格雷 RP-HPLC 治疗药物监测 

分 类 号：R917[医药卫生—药物分析学]