HPLC-MS/MS法测定人血浆中赖诺普利片的浓度

HPLC-MS/MS determination of lisinopril tablets in human plasma

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 of HPLC - MS/MS to detect lisinopril tablets in human plasma. Methods：Chromatographic column was Hypurity C18（2. 1 mm × 150 mm,5 μm） ;The mobile phase was 0. 1% formic acid - acetonitrile （30： 70） ;The flow rate was 0. 2 mL · min^-1 and temperature of column was 40℃. A MS/MS selective reaction monitoring mode was taken to quantitate lisinopril in human plasma. Results：Standard curve was linear in the range of 1.64 -210 ng · mL^-1 （r =0. 9915）. The lower limit of detections of lisinopril was 0. 82 ng · mL^-1. The absolute recovery was more than 50% ,and the relative recoveries of lisinopril were in the range of 80% - 120%. Relative standard deviations of intraday and interday assays of lisinopril were both less than 15%. Condusion： The method is convenient and sensitive for detecting the concentration of lisinopril in human plasma, it can be used to study the pharmacokinetics and bioequivalence of lisinopril.