高效液相色谱法测定人血浆中他林洛尔浓度  

HPLC determination of talinolol in human plasma

作　　者：何鑫[1,2] 阳国平[3] 谭志荣[1] 陈尧[1] 郭栋[1] 彭亮[1] 陈豪[1] 欧阳冬生[1] 

机构地区：[1]中南大学临床药理研究所,长沙410078 [2]长沙市三医院,长沙410010 [3]中南大学湘雅附三医院,长沙410013

出　　处：《药物分析杂志》2008年第6期857-860,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定人血浆中他林洛尔浓度的高效液相色谱-紫外检测法。方法:采用依利特Ⅱypersil—BDS C_(18)色谱柱(4.6 mm×200 mm,5 μm).乙睛-10 mmol·L^(-1)甲酸胺(20:80)为流动相,流速为1 mL·min^(-1),紫外检测波长为248 nm。结果:他林洛尔浓度在2.1～535 ng·mL^(-1)范围内,线性良好(r=0.9983),最低检测限1.0 ng·mL^(-1)(S/N>3),绝对回收率大于62.4%,符合生物样品分析要求。将建立的方法用于12名受试者单剂量口服(100 mg)他林洛尔片后不同时间血药浓度的测定。受试者口服他林洛尔片后,达峰时间 T_(max)为(2.4±1.0)h,峰浓度 C_(max)为(375±131)ng·mL^(-1),半衰期 T_(1/2)为(7.6±3.3)h,AUC_(0～48)为(2586±1266)ng·h·mL^(-1),AUC_(0～∞)为(2764±1409)ng·h·mL^(-1)。结论:本方法快速、经济、准确、灵敏,重现性好,可用于他林洛尔血药浓度监测和药代动力学研究。Objective：To establish a high performance liquid chromatography （HPLC） with ultraviolet visible detection method for determination of talinolol in human plasma. Method：The Hypersil -BDS C18 column （4.6 mm× 200 mm,5μm） was used as analytical column with a mobile phase consisted of 20% acetonitrile -10 mmol· L^-1 methanoic acid amine solution （20： 80）. The flow rate was 1.0 mL· min^-1 with ultraviolet visible detection set at 248 nm. Results： The standard curve was linear in the range of 2. 1 - 535 ng·mL^- 1 （ r = 0. 9983 ）. The lower limit of detection was 1.0 ng ·mL^-1 （ S/N 〉 3 ） and the absolute recovery of talinolol from plasma was more than 62.4%. The assay method was convenient for determination of talinolol. This method was used for detection of talinolol in plasma of 12 volunteers after a single oral dose of 100 mg tablets. The pharmacokinetic parameters of talinolol Tin=, C T1/2, AUC0-48 and AUC0-∞ were 2.4 ± 1.0 h,375 ±131 ng· mL^-1,7.6 ± 3.3 h,2586 ±1266 ng·h·mL^-1 and 2764 ± 1409 ng·h·mL^-1, respectively. Conclusion： The method is rapid, economical, accurate, sensitive and reproducible, for TDM （treatment drug monitor） and pharmacokinetic studies of talinolol in human plasma.

关 键 词：高效液相色谱 他林洛尔 药代动力学 

分 类 号：R917[医药卫生—药物分析学]