HPLC测定甲苯磺酸索拉非尼片及其在大鼠血浆中的含量

目的 建立高效液相色谱法测定索拉非尼含量,并探索大鼠血浆中索拉非尼浓度的测定方法。方法 采用EclipseXDB-C18色谱柱（150mm×4.6mm,5μm）;流动相：0.05%甲酸和0.05%三乙胺的水溶液-乙腈（35∶65）;流速：1.0mL·min1;柱温：30℃;检测波长：265nm。结果 索拉非尼浓度在0.4~12μg·mL1内线性关系良好,r=0.9999;加样回收率为100.8%,RSD为1.470%。大鼠按65mg·kg1灌胃给药,给药2.5h后,其血浆中索拉非尼的药物浓度为2.830μg·mL1。结论 本法可用于甲苯磺酸索拉非尼片中药物含量的测定,方法简单、灵敏,同时可检测大鼠血浆中索拉非尼的浓度。

Determination of Sorafenib in Tablet and Rat Blood Plasm by HPLC

OBJECTIVE To establish a high-performance liquid chromatography method for determination of sorafenib, explore a method of measuring the sorafenib concentration in rat blood plasma. METHODS Agilent Eclipse XDB-C18 column （150 mm×4.6 mm, 5 pro） was used. The mobile phase was 35%（0.05% formic acid and 0.05% triethylamine） in aqueous solution and 65% acetonitrile while the flow rate was 1.0 mL·min-1. The column temperature was 30 ℃. The detection wavelength was 265 nm. RESULTS The standard curve of sorafenib concentration was linear in the range of 0.4-12 μg·mL^-1（r=0.999 9）. The average recovery rate of the method was 100.8%, RSD was 1.470%. The rat was treated by gavage with sorafenib at the dosage of 65 mg-kg-l. The sorafenib concentration in rat blood plasm was 2.830 μg·mL^-1. CONCLUSION The method is suitable for the determination of sorafenib. It is practicable, simple, sensitive, and can be used to measure the sorafenib concentration in rat blood plasma.