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目的建立HPLC-MS/MS方法测定人血浆中的羧甲司坦体内浓度,用于人体生物等效性分析。方法以直接沉淀法处理血浆,色谱柱为XTerra MS C18柱(150mm×2.1mm,5μm);流动相为甲醇-20mmol.L-1甲酸铵(含0.5%甲酸)(75∶25,v/v);流速为0.3mL.min-1;柱温为40℃。采用电喷雾离子源(ESI)负离子模式,用多反应监测模式(MRM)进行定量分析。结果羧甲司坦线性范围为0.210 9～54μg.mL-1,定量下限为0.210 9μg.mL-1,绝对回收率>80%,日内和日间RSD均<15%。结论此方法能够简便、高效、快速和灵敏的检测健康志愿者血浆中的羧甲司坦,可用于羧甲司坦药物代谢动力学及生物等效性研究。
OBJECTIVE To establish an HPLC-MS / MS method for the determination of carposide in human plasma for bioequivalence analysis. Methods The plasma was treated by direct precipitation method. The column was XTerra MS C18 (150mm × 2.1mm, 5μm). The mobile phase consisted of methanol-20mmol.L-1 ammonium formate (containing 0.5% formic acid) (75:25, v / v ); Flow rate 0.3mL.min-1; column temperature 40 ℃. The electrospray ionization (ESI) negative ion mode was used for quantitative analysis with multiple reaction monitoring mode (MRM). Carbunate linear range of 0.210 9 ~ 54μg.mL-1, the lower limit of quantification of 0.210 9μg.mL-1, the absolute recovery> 80%, intraday and day RSD were <15%. Conclusion This method can be used for the determination of carbocisteine in the plasma of healthy volunteers simply, efficiently, rapidly and sensitively and can be used for the study of the pharmacokinetics and bioequivalence of carbocisteine.