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目的建立人血浆中沙格雷酯质量浓度的液相色谱-串联质谱(LC-MS/MS)测定方法。方法色谱柱为Elipse XDB-C18柱,流动相为乙腈-0.01 mol·L-1醋酸铵(体积比为65∶35),血浆样品经乙腈沉淀蛋白处理,以选择反应监测(selected reaction monitoring,SRM)扫描方式检测,测定健康男性受试者经口给予盐酸沙格雷酯后血浆中沙格雷酯的质量浓度。结果沙格雷酯线性为5.0~1 000μg·L-1,定量下限为5.0μg·L-1。日内、日间精密度(Relative Standard Deviation,RSD)均不大于9.0%,准确度(Relative Error,RE)为-6.5%~2.6%。沙格雷酯在健康男性血浆中主要药动学参数tmax为(0.49±0.21)h,ρmax为(725±264)μg·L-1,t1/2为(0.58±0.21)h,AUC0-t为(534±111)μg·h·L-1,AUC0-∞为(540±111)μg·h·L-1。结论该方法适用于沙格雷酯在健康人体内药动学的研究。
Objective To establish a liquid chromatography-tandem mass spectrometry (LC-MS / MS) method for the determination of sarpogrelate in human plasma. Methods The column was Elipse XDB-C18. The mobile phase consisted of acetonitrile-0.01 mol·L-1 ammonium acetate (65:35 by volume). The plasma samples were treated with acetonitrile precipitation and selected reaction monitoring (SRM ) Scanning method to determine the plasma concentration of sarpogrelate in healthy male subjects after oral administration of saguradronate hydrochloride. Results Sarregrel linearity 5.0 ~ 1 000μg · L-1, the lower limit of quantification was 5.0μg · L-1. The relative accuracy deviations (RSDs) were no more than 9.0% and the relative error (RE) was -6.5% -2.6%. The main pharmacokinetic parameters of sarpogrelate were (0.49 ± 0.21) h, (725 ± 264) μg · L-1, and t1 / 2 were 0.58 ± 0.21 h, and AUC0-t was (534 ± 111) μg · h · L-1, and the AUC0-∞ was (540 ± 111) μg · h · L-1. Conclusion This method is suitable for the pharmacokinetics of sarpogrelate in healthy volunteers.