HPLC测定炔雌醚含量和有关物质

Determination of Quinestrol and Its Related Substances by HPLC

目的建立HPLC测定炔雌醚含量和有关物质的方法。方法采用C18柱,以甲醇-水(90∶10)为流动相;流速为1.0 mL.min-1;检测波长为279nm。结果炔雌醚的线性范围为0.078 8～0.7884mg.mL-1(r=1.000 0),平均回收率为99.9%,RSD为0.80%(n=9),炔雌醚检测限浓度为0.06 g.mL-1。结论该方法简便、准确、专属性强,可作为产品质量检测方法。

OBJECTIVE To establish an HPLC method for content determination of quinestrol and its related substances.METHODS A C18 column was used with the mobile phase of water-methanol(90∶10).The flow rate was 1.0 mL·min 1,and the detection wavelength was 279 nm.RESULTS The calibration curve of quinestrol was linear in the range of 0.078 8 0.788 4 mg·mL 1(r=1.000 0),and the average recovery was 99.9%,RSD was 0.80%(n=9).The detection limit of quinestrol was 0.06 μg·mL 1.CONCLUSION The method is rapid,accurate and reliable for content determination of quinestrol and related substances.