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目的建立测定人血浆中比伐卢定浓度的液相色谱串联质谱方法。方法用Zorbax 300SB-C18色谱柱;流动相为甲醇-水-甲酸(55∶45∶0.45);流速为0.8 mL.min-1;柱温为35℃;正离子电离、多离子反应监测进行定量分析。结果比伐卢定线性范围为15～10000 ng.mL-1;批内、批间精密度均<10%;低、中、高浓度QC样品提取回收率均>98%。结论本方法专属、灵敏、准确、快速、简便,可用于比伐卢定的临床开发研究及上市后临床应用中的浓度测定。
Objective To establish a method for the determination of bivalirudin in human plasma by liquid chromatography-tandem mass spectrometry. Methods Zorbax 300SB-C18 column was used. The mobile phase consisted of methanol-water-formic acid (55:45:0.45), the flow rate was 0.8 mL.min-1 and the column temperature was 35 ℃. analysis. Results The linear range of bivalirudin was 15 ~ 10000 ng.mL-1. The intra- and inter-batch precision were less than 10%. The extraction recoveries of low, medium and high concentrations of QC samples were both> 98%. Conclusion This method is specific, sensitive, accurate, rapid and simple and can be used for the clinical development of bivalirudin and the concentration determination in clinical application after its listing.