高效液相色谱荧光检测法测定人血浆中替米沙坦浓度及其应用  

HPLC Determination with Fluorescent Detection of Telmisartan Concentration in Plasma and Its Application

作　　者：况荣华[1] 张会杰[2] 熊玉卿[2] 

机构地区：[1]江西医学院门诊部制剂室,南昌330006 [2]江西医学院临床药理研究所,南昌330006

出　　处：《药物分析杂志》2005年第6期629-632,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立高效液相色谱荧光检测人血浆中替米沙坦浓度的方法,并用于研究替米沙坦片的人体药代动力学。方法:采用固相萃取方法提取血浆中的替米沙坦,色谱柱为 Diamonsil C_(18)柱(5μm,4.6mm×150mm),以乙腈-磷酸二氢钾缓冲液(61∶39,磷酸调 pH=3.74)为流动相,流速1.0mL·min^(-1),坎地沙坦为内标,荧光检测波长λ_(Ex)=305nm,λ_(Em)=365nm。结果:本法测定替米沙坦的线性范围为0.5-144ng·mL^(-1),r=0.9998,绝对回收率在79.62%-85.69%(n=5),相对回收率在101.9%-109.0%(n=5),日内和日间 RSD 分别为4.23%-9.80%和4.03%-9.95%(n:5)。结论:本法灵敏、准确,操作简捷,适用于替米沙坦的血药浓度测定及药代动力学研究。Objective:To develop an HPLC method with fluorescent detection for the determination of telmisartan concentration in human plasma and apply to pharmacokinetic study of teimisartan.Methods:Telmisartan in plasma was extracted with solid phase extraction method.The column was Diamonsil C_(18)(5μm,4.6mm×150mm).The mobile phase consisted of acetonitrile-potassium dihydrogen phosphate buffer solution(61:39,adjusted pH to 3.74 with H_3PO_4)at a flow rate of 1 mL·min^(-1).The internal standard was candesartan.The fluorescence detector was operated at λ_(Ex)=305 nm and λ_(Em)=365nm.Results:The calibration curve of telmisartan was linear in the range of 0.5-144 ng·mL^(-1)(r=0.9998).The absolute recovery was 79.62%-85.69%(n=5),the relative recovery was 101.9%-109.0%(n=5),and the intra-day and inter-day RSD were 4.23%-9.80% and 4.03%-9.95%(n=5)respectively.Conclusion:This method possesses merits of good sensitivity,accuracy and simplicity.It is shown to be suitable for clinical monitoring concentration of telmisartan in human plasma and phar- maeokinetic studies of telmisartan in humans.

关 键 词：高效液相色谱荧光检测法 人血浆 人体药代动力学 药代动力学研究 血药浓度测定 替米沙坦片 磷酸二氢钾 萃取方法 C18柱 坎地沙坦 检测波长 线性范围 回收率 色谱柱 缓冲液 流动相 RSD 

分 类 号：R969.1[医药卫生—药理学] R978.3[医药卫生—药学]