中文摘要：

建立了DHEA衍生物含量测定和有关物质检查的方法。方法：采用Diamonsil C18（4.6mm×250mm;5μm）色谱柱,流动相为乙腈-水（45：55）,流速1.0mL/min,检测波长206nm。结果：在本文色谱条件下DHEA衍生物与有关物质能达到有效分离,在0.2～0.8mg/mL范围内线性关系良好,r=0.9998,仪器精密度RSD为0.2%（n=6）;重复性RSD为0.49%（n=9）,检测限为33ng。结论：该方法简便、准确、可行,可用于DHEA衍生物的质量控制。

英文摘要：

Objective：A reversed phase high performance liquid chromatography method for the determination of content of derivative of DHEA and its related substances is established.Methods： The analysis was performed on Diamonsil C18 reversed-phase analytical column（250mm ×4.6mm,5μm）;the mobile phase consisted of a mixture of acetonitrile-water（45：55） at the flow rate of 1.0mL/min;The ultraviolet detection wavelength was set at 206 nm.Results： Derivative of DHEA and its related substances could be seperated well.The linearity of the derivative of DHEA curve was well correlated（r =0.9998） within the range of 0.2-0.8mg/mL.The instrument precision RSD was 0.2%（n=6）;The method precision RSD was 0.49%（n=9）;The detection limit was 33 ng.Conclusion： The method appeared to be simple,accurate and reproducible;It can be used to control the quality of derivative of DHEA.