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·min-1. RESULTS. The calibration curve was linear over the range of 2.0∼20.0 μg·mL-1 and the measurable limit of detection was 0.2 μg·mL-1. The average recoveries of ornidazole at the concentrations of 2.0, 10.0, 20.0 μg·mL-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.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2003年第9期690-692,共3页
Chinese Pharmaceutical Journal
关键词
奥硝唑
血药浓度
高效液相色谱法
测定
药动学
Acetic acid
High performance liquid chromatography
Methanol
Pharmacokinetics
Ultraviolet detectors
