摘要:
目的:建立阿魏酸钠血药浓度测定方法并进行阿魏酸钠片的体内药动学研究。方法:采用高效液相色谱法,样品以甲醇处理,以替硝唑为内标,药物/内标峰高比定量。流动相为0.1%醋酸水溶液:乙腈(80:20);流速1.0mL/min;检测波长320 nm。结果:在血药浓度0.04～25.0μg/mL范围内阿魏酸钠线性关系良好(r=0.999 6),方法回收率为94.0%～103.6%,提取回收率>70%,日内、日间RSD<10%,检测限为4.12 ng/mL。阿魏酸钠片在Beagle犬体内的药动学过程符合双隔室一级吸收模型,t1/2(α)=(0.208±0.045)h,t1/2(β)=(2.228±0.927)h。结论:本方法专属性好、灵敏度高,适用于阿魏酸钠Beagle犬血药浓度测定及药动力学研究。
Abstract:
Objective :To establish a high-performance liquid chromatography method for analysis of sodium ferulate in Beagle dog plasma and to study the pharmacokinetics of sodium ferulate tablets. Methods :Sodium ferulate in plasma was extracted with methyl alcohol,separated on a Kromasil C18 column(200mm×4.6mm,5μm) and the peak height ratio of sodium ferulate to the internal standard tinidazole was measured.Plasma concentration of sodium ferulate was determined at 320 nm using 0.1% acetic acid solution:acetonitrile(80:20) as the mobile phase and the flow rate was 1.0 mL/min. Results :Sodium ferulate was linear in the range of 0.04～25.0 μg/mL(r=0.999 6).The recovery of sodium ferulate was in the range of 94.0%～103.6%.The ABSolute recovery was more than 70%.The relative standard deviations of intra-day and inter-days were less than 10%.The minimum detectable concentration of sodium ferulate was 4.12 ng/mL.The plasma concentration-time curve of sodium ferulate oral tablet was found to be two-compartment model,and t1/2(α) was(0.208±0.045) h,t1/2(β) was(2.228±0.927) h. Conclusion :The method is sensitive,specific for the quantitative determination of sodium ferulate in the plasma of Beagle dog.It is suitable for pharmacokinetics study of sodium ferulate.
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