摘要
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,5μm）;以0.02 mol/L磷酸二氢钾溶液（用磷酸调节p H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 m L/min;进样体积20μL。结果安立生坦R异构体在0.501~4.008μg/m L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 p H 4 with phosphoric acid）- acetonitrile, 80：20 as mobile phase; detection wavelength, 220 nm; column temperature, 30 ℃; flow rate, 1 m L/min; volume of sample, 20 μL. Results A good linear relationship was obtained in the range of 0.501— 4.008 μg/m L（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.
出处
《药物评价研究》
CAS
2015年第2期185-188,共4页
Drug Evaluation Research
