目的 建立HPLC法测定安立生坦中R异构体的方法。方法 采用HPLC法, 用硅胶键合蛋白质型手性色谱柱ULTRON ES-OVM(150 mm×4.6 mm, 5 μm);以0.02 mol/L磷酸二氢钾溶液(用磷酸调节pH至4.0)-乙腈(80:20)为流动相;检测波长220 nm;柱温30 ℃;体积流量为1.0 mL/min;进样体积20 μL。结果 安立生坦R异构体在0.501～4.008 μg/mL与峰面积线性关系良好(r=0.999 3), 平均回收率为98.62%, RSD值为2.82%(n=12)。结论 本法操作简便快速, 结果准确可靠, 可用于安立生坦中R异构体的控制。

Objective To establish an HPLC method for the determination of R optical isomer in ambrisentan. Methods The HPLC was performed on a ULTRON ES-OVM column (250 mm × 4.6 mm, 5 μm); potassium dihydrogen phosphate solution (0.02 mol/L, adjusted to pH 4 with phosphoric acid)-acetonitrile, 80:20 as mobile phase; detection wavelength, 220 nm; column temperature, 30 ℃; flow rate, 1 mL/min; volume of sample, 20 μL. Results A good linear relationship was obtained in the range of 0.501—4.008 μg/mL (r=0.999 3), and the average recovery was 98.62% with RSD of 2.82% (n = 12). Conclusion The method is convenient, rapid, accurate, and can be used for the determination of R optical isomer in ambrisentan.