HPLC法测定人血浆中氨苄西林含量及其药动学研究

目的:建立以高效液相色谱法测定人血浆中氨苄西林浓度的方法。方法:色谱柱为WatersSunfireC18,流动相为乙腈-0.05mol.L-1磷酸二氢钾溶液(6.5∶93.5),检测波长为210nm,柱温为35℃,流速为1.2mL·min-1,进样量为20μL。结果:血样中氨苄西林检测浓度在0.2～16.0μg.mL-1范围内线性关系良好(r=0.9999);最低定量限为0.2μg.mL-1;平均方法回收率为99.88%～104.45%,平均提取回收率为95.69%～100.56%,日内和日间RSD均<10%。结论:本方法稳定、快捷、灵敏,适用于氨苄西林制剂的人体药动学研究。

Determination of Concentration and Pharmacokinetics of Ampicillin in Human Plasma by HPLC

OBJECTIVE： To determine ampicillin concentration in human plasma by HPLC. METHODS： The chromatographic column was Waters Sunfire C18 with mobile phase consisted of acetonitrile and 0.05 mol· L^-1 potassium dihydrogen phosphate（6.5 ： 93.5, V ： V） at a flow rate of 1.2 mL ·min^ -1. The UV detection wavelength was 210 nm; the column temperature was 35℃ and the injection volume was 20μL. RESULTS： The linear range of ampicillin was 0.2-16.0 μg · mL^ -1（r = 0.999 9）. The limit of quantization was 0.2μg· mL^ -1. The average methodological recovery was 99.88%- 104.45%, and the average extraction recovery was 95.69%- 100.56%. Both the inter-day RSD and the intra- day RSD were all less than 10%. CONCLUSION： This method is stable, rapid and sensitive, and suitable for the pharmacokinetic study for ampicillin preparation.