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HPLC测定黄体酮中的有关物质
引用本文:张立雯,冉兰,晁若冰.HPLC测定黄体酮中的有关物质[J].华西药学杂志,2006,21(6):570-572.
作者姓名:张立雯  冉兰  晁若冰
作者单位:1. 广州市药品检验所,广东,广州,510160
2. 四川大学华西药学院,四川,成都,610041
摘    要:目的建立测定黄体酮原料药中20β-羟基-黄体酮等多种有关物质的方法。方法采用HPLC法,C18色谱柱,以甲醇-乙腈-水(35:35:30)为流动相,检测波长241 nm。结果黄体酮与20β-羟基-黄体酮等6种杂质分离良好,并对黄体酮中的有关物质进行了鉴定。采用加校正因子的主成分自身对照法测定了黄体酮样品中有关物质的含量。结论所建方法可以同时分离并测定黄体酮中的有关物质,方法简便、可靠。

关 键 词:高效液相色谱法  黄体酮  有关物质
文章编号:1006-0103(2006)06-0570-03
收稿时间:2006-04
修稿时间:2006年4月1日

Determination of related substances in progesterone by HPLC
ZHANG Li-wen,RAN Lan,CHAO Ruo-bing.Determination of related substances in progesterone by HPLC[J].West China Journal of Pharmaceutical Sciences,2006,21(6):570-572.
Authors:ZHANG Li-wen  RAN Lan  CHAO Ruo-bing
Affiliation:1. Guangzhou Institute for Drug Control, Guangzhou 510160, China; 2. West China School of Pharmacy, Sichuan University, Chengdu 610041, China
Abstract:OBJECTIVE To determine the related substances in progesterone.METHODS An HPLC method was established,using methanol-acetonitrile-water(35:35:30) as mobile phase,separating through C_(18) column and detecting at 241 nm.RESULTS Progesterone and 6 related substances could be separated well.The corrective factors of the 5 known impurities were determined.The impurities in progesterone were identified and determined.CONCLUSION This method can be used to simultaneously separate and determine the related substances in progesterone.It is simple and accurate.
Keywords:HPLC  Progesterone  Related substances
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