外消旋达卢生坦的HPLC法手性拆分及含量测定

Enantiomeric Separation and Determination of Racemic Darusentan by HPLC

建立了HPLC法拆分外消旋达卢生坦对映体,并进行了含量测定。采用ES-OVM柱,以30mmol/L磷酸盐缓冲液(pH3.35)-乙腈(60︰40)为流动相,检测波长248nm。达卢生坦及其R-型异构体在0.01～0.10mg/ml浓度范围内线性关系良好。平均回收率为99.6%和99.5%,RSD为0.75%和0.82%。

An HPLC method was established for the enantiomeric separation and determination of racemic darusentan.An ES-OVM column was used with the mobile phase of 30 mmol/L phosphate buffer（pH 3.35）-acetonitrile（60：40） at the detection wavelength of 248 nm.The calibration curves of darusentan and its（R）-isomer were linear in the concentration range of 0.01-0.10 mg/ml.The recoveries were 99.6% and 99.5%,with RSDs of 0.75% and 0.82%.