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目的建立测定人体内红霉胺血药质量浓度的液相色谱-串联质谱法(LC-MS-MS),为地红霉素药物动力学研究提供方法学依据。方法待测血浆0.5 mL用乙醚-二氯甲烷萃取。色谱柱:Zob-ax XDB C18柱;流动相:甲醇-水-甲酸(体积比80∶20∶0.5);流速:0.6 mL.min-1。液相色谱-串联质谱采用多反应离子检测,正离子模式。结果血浆中无干扰测定的内源性物质;每个样品分析时间小于4 min;线性范围为1.0~1000μg.L-1,定量下限为1.0μg.L-1;批内、批间精密度均小于15%。结论LC-MS-MS法可用于红霉胺的临床药物动力学研究。
OBJECTIVE To establish a liquid chromatography-tandem mass spectrometry (LC-MS-MS) method for the determination of erythromycylamine in human body, and provide a methodological basis for the pharmacokinetics study of erythromycin. Methods 0.5 mL of plasma was extracted with ether-dichloromethane. Column: Zob-ax XDB C18 column; mobile phase: methanol-water-formic acid (volume ratio 80:20:0.5); flow rate: 0.6 mL.min-1. Liquid chromatography - tandem mass spectrometry using multiple reactive ion detection, positive mode. Results There was no interference with the endogenous substances in the plasma. The analysis time of each sample was less than 4 min. The linear range was 1.0-1000 μg.L-1 and the lower limit of quantification was 1.0 μg.L-1. Less than 15%. Conclusion LC-MS-MS method can be used for the clinical pharmacokinetics of erythromycylamine.