高效液相色谱法测定尼尔雌醇含量方法的建立

摘　要：目的：建立尼尔雌醇含量测定的HPLC方法。方法：以InertsilODS-3和HYPERSILODS为固定相，甲醇-水(80∶20)为流动相，在检测波长221nm的条件下分离测定尼尔雌醇，并对方法进行了认证。结果：在建立的色谱条件下，尼尔雌醇与其杂质能完全分离，在浓度20.08～200.8μg·mL^-1范围内线性关系良好，相关系数为0.9999。结论：本法准确、方便、可靠。

关键词：尼尔雌醇　高效液相色谱

分类号：R927　文献标识码：A

Development of HPLC Determination of Nilestriol

ZHANG Xin-yun（Shanghai Institute for Drug Control,200233）　
LI Jian-hua（Shanghai Institute for Drug Control,200233）　
YANG Yong-jian（Shanghai Institute for Drug Control,200233）　

Abstract：Objective：To develop a HPLC method for determination of nilestriol.Methods:Chromatographic condition was,column:C18;mobile phase:methanol-water (80∶20),detection wavelength:221 nm.Two types of column,Inertsil ODS-3 and HYPERSIL ODS,and products produced in the acidic solution,basic solution,H2O2 solution or by being exposed to light were used to validate this method.Results:Under the described chromatogaphic condition nilestriol was completely separated from its impurities.The relationship between response and the concentration in the range of 20.08～200.8 μg^.mL^-1 is linear,the correlation coefficent is 0.999 9.Conclusion:This method is accurate,convenient and reliable.

Keywords：nilestriol，HPLC

参考文献：

［1］ChP(中国药典).1995.Vol Ⅱ(二部)：192

收稿日期：2000年1月17日

出版日期：2001年3月31日