奥硝唑血药浓度的高效液相色谱法测定及其药动学研究  

Determination of ornidazole in plasma by HPLC and study on its pharmacokinetics

作　　者：李芹[1] 赵焰[2] 梁永广[1] 王本杰[3] 

机构地区：[1]山东省聊城市人民医院药学部,山东聊城252000 [2]山东大学药学院药剂实验室,山东济南250012 [3]山东大学齐鲁医院临床药理研究所,山东济南250012

出　　处：《中国药学杂志》2003年第9期690-692,共3页Chinese Pharmaceutical Journal

摘　　要：目的　建立血浆中奥硝唑浓度的反相高效液相色谱分析方法 ,并用此法研究奥硝唑的人体药动学。方法　采用Kro masilC18色谱柱 ,以甲醇 0 .4 %HAc(5 0∶5 0 )为流动相 ,流速 0 .8mL·min-1,紫外检测波长 316nm。结果　奥硝唑在 2 .0～2 0 .0 μg·mL-1范围内呈线性 ,r =0 .9997,最低检测限 0 .2 μg·mL-1。低、中、高浓度 (2 .0 ,10 .0 ,2 0 .0 μg·mL-1)的方法回收率分别为 10 0 .36 % ,98.2 1%和 97.4 2 % ,日间及日内RSD分别 <6 %和 <7%。药动学研究表明 ,口服奥硝唑国产与进口制剂的药 时曲线符合有滞后时间的二室模型。结论　本法准确可靠 ,操作简便 ,适用于临床药动学研究及常规血药浓度监测。OBJECTIVE: A reversed HPLC method was established for the determination of ornidazole in human plasma. Its pharmacokinetic investigation was studied in healthy volunteers. METHODS: The drug was extracted from plasma with methanol and isopropanol (50:50), and then detected by UV detector at 316nm with a C 18 5 μm, 250 nm × 4.6 mm column. The mixture of methanol and 0.4% glacial acetic acid (50:50) was used as the mobile phase. The flow rate was 0.8 mL&middotmin-1. RESULTS. The calibration curve was linear over the range of 2.0∼20.0 μg&middotmL-1 and the measurable limit of detection was 0.2 μg&middotmL-1. The average recoveries of ornidazole at the concentrations of 2.0, 10.0, 20.0 μg&middotmL-1 were 100.36%, 98.21% and 97.42%, respectively. The RSDs of the within-day and between-day variations were less than 7% and 6% respectively. The results showed that the concentration time curves of the two preparations were fitted to a two compartment model with a lag time. CONCLUSION: This HPLC method is simple, sensitive and accurate. It is suitable for routine determination of ornidazole levels in human plasma and for its pharmacokinetic study.

关 键 词：奥硝唑 血药浓度 高效液相色谱法 测定 药动学 

分 类 号：R978.61[医药卫生—药品] R969.1[医药卫生—药学]