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目的:建立高效、灵敏、快速的UPLC-ESI-MS/MS测定人血浆中克拉霉素浓度的方法,并应用于药动学研究。方法:血浆样品先经碳酸钠溶液碱化,经乙醚液-液萃取后,以0.05 mol·L-1乙酸铵水溶液-乙腈为流动相进行梯度洗脱,色谱柱采用BEH C18(50 mm×2.1 mm,1.7μm)色谱柱,克拉霉素和内标罗红霉素定量分析的离子对分别为m/z 748.6→157.9和m/z 837.0→679.2。结果:克拉霉素的线性范围为1~3 000 ng·m L-1且线性关系良好,日内日间精密度均小于10.0%,准确度在-7.6%~6.0%之间,样品运行时间为2.0 min。结论:该法灵敏、快速,适用于克拉霉素高通量样本的分析,已成功应用于克拉霉素人体药动学研究。
OBJECTIVE: To establish an efficient, sensitive and rapid UPLC-ESI-MS / MS method for the determination of clarithromycin in human plasma and its application in pharmacokinetic studies. Methods: The plasma samples were alkalized by sodium carbonate solution and eluted with ethyl acetate solution. The mobile phase was eluted with 0.05 mol·L-1 ammonium acetate-acetonitrile as mobile phase. The mobile phase was BEH C18 (50 mm × 2.1 mm, 1.7 μm), m / z 748.6 → 157.9 and m / z 837.0 → 679.2 respectively for the clarithromycin and the internal standard roxithromycin. Results: The linear range of clarithromycin was 1-3000 ng · m L-1 with a good linearity. The intra-day and inter-day precision were less than 10.0% and the accuracy was between -7.6% and 6.0%. The running time of clarithromycin was 2.0 min. Conclusion: The method is sensitive, rapid and suitable for the analysis of clarithromycin high-throughput samples and has been successfully applied to the clarithromycin human pharmacokinetic study.