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目的建立简单、快速和灵敏的高效液相色谱串联质谱联用法测定人血浆中克仑特罗的浓度。方法采用Agilent Eclipse XDB-C18色谱柱(4.6 mm×50 mm,1.8μm),流动相为乙腈-0.1%甲酸=30∶70(v/v),流速为0.5 mL.min-1,柱温为25℃,通过电喷雾离子源进入质谱,以二级质谱多反应监测(MRM)方式对克仑特罗进行检测。结果克仑特罗的线性范围为5.45~1090 pg.mL-1,LLOQ为5.45 pg.mL-1,平均相对回收率在80%~120%范围内,日内和日间变异均<15%。结论本法简单、快速、灵敏、重现性好,能够用于克仑特罗的人体药物动力学和生物等效性研究。
Objective To establish a simple, rapid and sensitive HPLC-MS / MS method for the determination of clenbuterol in human plasma. Methods Agilent Eclipse XDB-C18 column (4.6 mm × 50 mm, 1.8 μm) was used. The mobile phase was acetonitrile-0.1% formic acid = 30:70 v / v and the flow rate was 0.5 mL.min-1. At 25 ℃, mass spectrometry was carried out by electrospray ionization and the clenbuterol was detected by two-dimensional mass spectrometry multiple reaction monitoring (MRM). Results The linear range of Clenbuterol was 5.45-1090 pg.mL-1, and the LLOQ was 5.45 pg.mL-1. The average relative recoveries ranged from 80% to 120%. The intra- and inter-day variation was less than 15%. Conclusions This method is simple, rapid, sensitive and reproducible. It can be used to study the pharmacokinetics and bioequivalence of clenbuterol.