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目的建立LC-MS/MS同时测定人血浆中阿莫西林/氨溴索浓度。方法以Lichrospher C18(4.6mm×150mm,5μm)为色谱柱,流动相为甲醇溶液(含0.2%甲酸)和水溶液(含0.2%甲酸),采用梯度洗脱进行分析,流速为1.0mL·min-1,柱温为30℃。血浆样品经甲醇沉淀后进样,采用多反应监测(MRM)方式对样品进行测定。结果血浆中阿莫西林线性范围为5～20000μg·L-1,氨溴索线性范围为1～200μg·L-1;批间和批内精密度RSD均小于9%;方法的准确度为(100±7)%;最低定量限浓度(LLOQ)阿莫西林为5μg·L-1,氨溴索为1μg·L-1。结论本试验建立了同时测定阿莫西林和氨溴索浓度的方法,该方法灵敏、准确、简便、快速,适用于阿莫西林/氨溴索人体药动学研究。
Objective To establish a simultaneous LC-MS / MS method for the determination of amoxicillin / ambroxol in human plasma. Methods The mobile phase consisted of methanolic solution (containing 0.2% formic acid) and aqueous solution (containing 0.2% formic acid) with gradient elution on a Lichrospher C18 column (4.6 mm × 150 mm, 5 μm) with a flow rate of 1.0 mL · min- 1, the column temperature is 30 ℃. The plasma samples were injected after methanol precipitation and the samples were determined by multiple reaction monitoring (MRM). Results The linear range of amoxicillin in plasma was 5 ~ 20000μg · L-1 and the linear range of ambroxol was 1 ~ 200μg · L-1. The RSDs of intra-batch and intra-batch precision were all less than 9%. The accuracy of the method was ( 100 ± 7)%. The lowest limit of quantitation (LLOQ) was 5 μg · L-1 for amoxicillin and 1 μg · L-1 for ambroxol. Conclusions This study established a method for simultaneous determination of amoxicillin and ambroxol. The method was sensitive, accurate, simple and rapid and suitable for the study of human pharmacokinetics of amoxicillin / ambroxol.