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HPLC法测定人血浆中比阿培南的浓度及其药动学研究

Studies on the concentration and bioequivalence of the Biapenem in human plasma by HPLC

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【作者】 张爱丽; 兰婷; 李穆琼; 张俊娜; 李晓晔;

【Author】 ZHANG Aili,LAN Ting,LI Muqiong,ZHANG Junna,LI Xiaoye Department of Chemistry,School of Pharmacy,the Fourth Military Medical University,Shaanxi Province,Xi ′an 710032,China

【机构】 第四军医大学药学系化学教研室;

【摘要】 目的:建立人血浆中比阿培南的高效液相色谱检测方法。方法:色谱柱为Agilent ZORBAX Bonus-RP(4.6 mm×250 mm,5μm);流动相为甲醇和0.03%醋酸水溶液,采用梯度洗脱法;流速为1.00 ml/min;检测波长为300 nm,血浆样品处理选用5-羟基吲哚乙酸为内标,采用硫酸锌沉淀蛋白。结果:比阿培南在0.2~50.0μg/ml范围内线性良好,HPLC测定定量下限为0.2μg/ml,比阿培南和内标在血浆的保留时间分别为3.9 min和9.7 min,出峰迅速。比阿培南浓度分别为0.5、5.0和40.0μg/ml,血浆样本回收率分别为101.8%、100.8%、100.4%;精密度试验日内和日间RSD均小于15%,稳定性试验结果表明血浆样品在样品处理过程中较稳定(RSD<15%)。结论:本方法灵敏度高,操作简便,快速,重复性好,适用于比阿培南血浆浓度的测定。

【Abstract】 Objective: To establish a method for the determination of Biapenem in human plasma by HPLC.Methods: Agilent ZORBAX Bonus-RP(4.6 mm×250 mm,5 μm) was used as the analytical column;mobile phase was composed of methanol-0.03% acetic acid solution(gradient elution);the flow rate was 1.00 ml/min;the UV detection was carried out at 300 nm.The plasma samples were performed by protein precipitation with ZnSO4 using 5-hydroxyindole acetic acid as internal standard sample.Results: The assay was linear over the concentration range of 0.2-50.0 μg/ml for Biapenem in human plasma.The limit of quantitation for biapenem was 0.2 μg/ml.The retention time of Biapenem and internal standard sample in plasma was 3.9 min and 9.7 min,respectively.The recovery rate at concentrations of 0.5,5.0,40.0 μg/ml were 101.8%,100.8%,100.4%,respectively.The method was accurate with all intra-day and inter-day mean concentrations within 15% of nominal values.Furthermore,the stability results showed that Biapenem was stable during sample processing(RSD<15%).Conclusion: This method is high sensitive,operation simple,fast and repeatable,which is suitable for determination of Biapenem in human plasma.

【关键词】 比阿培南; 高效液相色谱法; 梯度洗脱;
【Key words】 Biapenem; HPLC; Gradient elution;
  • 【文献出处】 中国医药导报 ,China Medical Herald , 编辑部邮箱 ,2011年35期
  • 【分类号】R96
  • 【被引频次】1
  • 【下载频次】141
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