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目的:建立快速测定血清和尿样中头孢他啶含量的HPLC法,进行药代动力学研究。方法:采用Alltima C18(53mm×7mm,3μm)色谱柱,流动相为0.02mol·L-1磷酸二氢钾-甲醇(85∶15,v/v),流速为2mL·min-1,检测波长为254nm。结果:血清样品在0.25～50μg·mL-1范围内,尿样在1.25～250μg·mL-1范围内呈现良好的线性关系。对血清样品和尿样,平均回收率分别为95%～115%和102%～105%,日内和日间RSD均小于6.0%。整个分析时间约3min。12名受试者静脉给予1000mg头孢他啶后,获得的主要药代动力学参数为Cmax(70.58±8.23)μg·mL-1,t1/2(1.89±0.57)h,AUC0-24(139.0±19.5)μg·h·mL-1,0～24h尿累计排泄率为(78.9±17.2)%。结论:与5μm填料色谱柱常规分析所需相比,3μm填料的色谱柱可以显著提高测试速度。本方法简便、快速和准确,可用于头孢他啶的药代动力学研究。
OBJECTIVE: To establish a rapid HPLC method for the determination of ceftazidime in serum and urine samples for pharmacokinetic studies. METHODS: Alltima C18 (53 mm × 7 mm, 3 μm) column was used. The mobile phase consisted of 0.02 mol·L-1 potassium dihydrogen phosphate-methanol (85:15 v / v) at a flow rate of 2 mL · min- 254 nm. Results: Serum samples showed good linearity in the range of 1.25 ~ 250μg · mL-1 within the range of 0.25 ~ 50μg · mL-1. For serum samples and urine samples, the average recoveries were 95% -115% and 102% -105%, respectively, with intraday and interday RSDs less than 6.0%. The whole analysis time is about 3min. The main pharmacokinetic parameters of Cmax (70.58 ± 8.23) μg · mL-1, t1 / 2 (1.89 ± 0.57) h and AUC0-24 (139.0 ± 19.5) were obtained after intravenous administration of 1000 mg ceftazidime to 12 subjects. μg · h · mL-1, urine accumulative excretion rate of 1 to 24 hours was (78.9 ± 17.2)%. Conclusion: A 3 μm column can significantly increase the speed of the test compared to that required for routine analysis on a 5 μm packed column. The method is simple, rapid and accurate and can be applied to the pharmacokinetics of ceftazidime.