HPLC测定炔雌醚含量和有关物质

Determination of Quinestrol and Its Related Substances by HPLC

摘要: 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279 nm。结果炔雌醚的线性范围为0.078 8~0.788 4 mg·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 mg·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。

Abstract: 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.