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目的:建立高效液相色谱-质谱/质谱联用测定人血浆中赖诺普利浓度的方法,用于赖诺普利口腔崩解片的人体相对生物利用度和生物等效性研究。方法:使用Hypurity C18柱(2.1mm×150mm,5μm),以0.1%甲酸-乙腈(30∶70)为流动相,流速为0.2mL·min-1,柱温为40℃。以二级质谱选择离子反应监测方式(SRM)扫描检测。结果:赖诺普利的线性浓度范围为1.64～210ng·mL-1(r=0.9915),最小检出浓度为0.82ng·mL-1。提取回收率大于50%,平均相对回收率在80%～120%范围内。日内与日间变异均小于15%。结论:本法简便、灵敏,可用于赖诺普利的药物代谢动力学和生物等效性研究。
OBJECTIVE: To establish a method for the determination of concentration of lisinopril in human plasma by high performance liquid chromatography-mass spectrometry / mass spectrometry and to study the relative bioavailability and bioequivalence of lisinopril orally disintegrating tablets. Methods: Hypurity C18 column (2.1 mm × 150 mm, 5 μm) with 0.1% formic acid-acetonitrile (30:70) was used as the mobile phase at a flow rate of 0.2 mL · min-1 and the column temperature was 40 ℃. Secondary MS selected ion reaction monitoring (SRM) scan detection. Results: The linear range of lisinopril was 1.64 ~ 210 ng · mL-1 (r = 0.9915), the minimum detectable concentration was 0.82 ng · mL-1. The extraction recovery was more than 50%, the average relative recovery was in the range of 80% ~ 120%. Intra-day and inter-day variations were less than 15%. Conclusion: This method is simple and sensitive and can be used for the study of pharmacokinetics and bioequivalence of lisinopril.