HPLC法测定心舒口服液中阿魏酸血浆浓度及其在大鼠体内的药动学研究

Determination of plasma level of ferulic acid in Xinshu Oral Liquid by HPLC and its in vivo pharmacokinetics in rats

目的 建立测定血浆中阿魏酸浓度的 HPL C法 ,并用于心舒口服液中阿魏酸在大鼠体内的药动学研究。方法 色谱柱为 Nucleosil C1 8柱 ,流动相为甲醇 -水 -冰乙酸 (35∶ 6 5∶ 0 .1) ,流速为 1.0 m L / m in,检测波长为 32 0 nm。以替硝唑为内标 ,血浆样品酸化后用醋酸乙酯提取。结果 标准曲线线性范围 0 .2 5～ 16 .0 m g/ L,r=0 .9992。阿魏酸平均回收率 96 .9%～ 10 0 .6 % ,最低检测浓度为 0 .2 m g/ L,日内 RSD<3.0 % ,日间 RSD<5 .3%。心舒口服液中阿魏酸在大鼠体内的药 -时曲线符合二房室模型 ,T1 /2α为 12 .6 m in,T1 /2β为 30 5 m in。结论 方法简便、快速、准确、重现性好 ,适用于阿魏酸血药浓度测定及药代动力学研究。

Object To develop an HPLC method for the determination of plasma level of ferulic acid and study the in vivo pharmacokinetics in rats. Methods The used analytical column was Nucleosil C_ 18 . The mobile phase was methanol-water-acetic acid (35∶65∶0.1). The flow rate was 1.0 mL/min and detection wavelength at 320 nm. Plasma samples were prepared for analysis by addition of internal standard (Tinidazole) followed by extracting with ethyl acetate. Results Linear caliration curve was obtained by plotting concentration vs peak area ratio over the rang 0.25—16.0 mg/L with a correlation coefficient of 0.999 2. The average recovery of ferulic acid was 96.9%—100.6%. The minimum detectable concentration of ferulic acid was 0.2 mg/L. The relative standard deviations for within-day and between-days were less than 3.0% and 5.3%,respectively. The plasma concentration-time curve of ferulic acid in Xinshu Oral Liquid ig given to rats was found to fit a two-compartments model with T_ 1/2α of 12.6 min and T_ 1/2β of 305 min. Conclusion The method is simple,rapid,accurate,and precise, which can be used for the determination of plasma level of ferulic acid and the study of its pharmacokinetics.