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目的建立测定人血浆中硝苯地平的高效液相色谱-质谱联用(HPLC-MS/MS)方法。方法血浆样品经乙腈沉淀蛋白提取分离,色谱柱为Utimat AQ-C18,流动相为乙腈-20 mmol·L-1醋酸铵(58∶42),流速为0.30mL·min-1,柱温:40℃,电喷雾负离子源(ESI-),用多反应离子检测(MRM)。结果硝苯地平线性范围为0.03~80.00 ng·mL-1,定量下限为0.03 ng·mL-1,提取回收率在94.7%~102.3%,日内、日间RSD均小于9.8%。结论本方法专属性强,灵敏度高,操作简便、快速、准确,适用于硝苯地平缓释片药代动力学研究。
Objective To establish a high performance liquid chromatography-mass spectrometry (HPLC-MS / MS) method for the determination of nifedipine in human plasma. Methods The plasma samples were separated by acetonitrile precipitation. The column was Utimat AQ-C18. The mobile phase consisted of acetonitrile-20 mmol·L-1 ammonium acetate (58:42), the flow rate was 0.30 mL · min-1 and the column temperature was 40 ℃, electrospray negative ion source (ESI-), with multiple reactive ion detection (MRM). Results The linear range of nifedipine was 0.03-80.00 ng · mL-1 with the lower limit of quantitation of 0.03 ng · mL-1. The recoveries of nifedipine ranged from 94.7% to 102.3%. The intra-day and inter-day RSD were less than 9.8%. Conclusion This method is specific, sensitive and easy to operate. It is fast, accurate and suitable for the study of pharmacokinetics of nifedipine sustained-release tablets.