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目的:建立以高效液相色谱法测定人血浆中比阿培南浓度的方法。方法:色谱柱为Hypersil ODS,流动相为乙腈-0.1mol.L-1乙酸钠缓冲液(2:98,pH4.38),流速为1.0mL.min-1,检测波长为300nm,柱温为25℃,进样量为20μL,样品温度为10℃。结果:比阿培南血药浓度在0.2～50μg.mL-1范围内线性关系良好(r=0.9997),最低检测限为0.2μg.mL-1。最低、低、中、高(0.2、0.5、5、50μg.mL-1)浓度血浆样品中的比阿培南的平均提取回收率分别为105.8%、91.5%、86.84%、97.00%,内标的平均回收率为97.04%;4种浓度的日内、日间RSD均<15%,均满足生物样品测定要求。结论:本方法简便、准确、快速、灵敏、专属性强、重现性高,可用于比阿培南人体药动研究。
Objective: To establish a method for the determination of biapenem concentration in human plasma by high performance liquid chromatography. Methods: The chromatographic column was Hypersil ODS. The mobile phase was acetonitrile-0.1mol.L-1 sodium acetate buffer (2: 98, pH4.38) at a flow rate of 1.0mL.min-1. The detection wavelength was 300nm and the column temperature was 25 ℃, injection volume of 20μL, the sample temperature is 10 ℃. Results: The linearity of biapenem in the range of 0.2 ~ 50μg.mL-1 was good (r = 0.9997), the lowest detection limit was 0.2μg.mL-1. The average recoveries of biaperenan in the lowest, middle, high, and low (0.2,0.5,5,50μg.mL-1) plasma samples were 105.8%, 91.5%, 86.84% and 97.00%, respectively. The internal standard The average recovery rate was 97.04%. The daily and intraday RSDs of all four concentrations were less than 15%, which all met the requirements of biological samples. Conclusion: The method is simple, accurate, rapid, sensitive, specific and reproducible. It can be used in the study of biapenem pharmacokinetics in human body.