高效液相色谱法测定人血浆中噁丙嗪分散片的浓度及药动学

Determination of the concentration and pharmacokinetic of Oxaprozin dispersible tablet in human plasma by HPLC

目的 建立高效液相色谱法测定人血浆中丙嗪分散片浓度的方法。方法 高效液相色谱法 ,色谱柱为KromasilC18(6 .0mm× 15 0mm ,5 μm) ,流动相为甲醇∶水 (6 5∶35 )。血浆样品用乙醚提取。 结果 丙嗪的线性范围为3.12 5～ 10 0mg/L ,最低检测浓度为 3.12 5mg/L。高、中、低 3种浓度 (10 0 ,2 5 ,6 .2 5mg/L)的日内、日间变异均小于15 %。结论 该方法灵敏、精确、稳定 ,适用于丙嗪生物样本的测定和药代动力学研究。

Objective To develop an HPLC method for the determination of Oxaprozin dispersible table in human plasma.Methods The analytical column was kromasil C 18(6.0mm×150mm,5μm).The mobile phase was methol∶water(65∶35).And the plasma sample was extracted with aether.Results The calibration curve was linear within the range of 3.125～100mg/L.The lower limit of detection was 3.125mg/L.Intra-day and inter-day RSDs for assaying the plasma sample containing three concentrations of Oxaprozin were less than 15%.Conclusion An HPLC method is established to determine Oxaprozin in plasma.The method has good in selectivity,sensitivity,accuracy and stability,which is suitable for the study of pharmacokinetics of Oxaprozin.