【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 C₁₈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。更多还原

【Abstract】 Objective:To establish a high performance liquid chromatography （HPLC） with ultraviolet visible de- tection method for determination of talinolol in human plasma.Method:The Hypersil-BDS C₁₈ column （4.6 mm× 200 mm,5 μm） 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 tali- nolol in plasma of 12 volunteers after a single oral dose of 100 mg tablets.The pharmacokinetic parameters of talino- lol T_max,C_max,T_1/2,AUC_0-48 and AUC_0-∞ 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,sen- sitive and reproducible,for TDM （treatment drug monitor） and pharmacokinetic studies of talinolol in human plas- ma.更多还原