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探亲避孕药双炔失碳酯中α、β异构体分离和含量测定方法的研究

Studies on Isolation of Isomers and Assay of Anordrin

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【作者】 田敏宋育文

【Author】 Tian Min and Song Yuwen(National Institute for the Control of Pharmaceutical and Biological Products,Beijing,100050)

【机构】 中国药品生物制品检定所

【摘要】 介绍了反相高效液相色谱法分离避孕药双炔失碳酯中α、β异构体的方法及其中α体的含量测定方法.采用ZorbaxODSC18柱,以己酸孕酮为内标,乙腈-水(90∶10)为流动相,检测波长208nm,测得线性范围2~12μg,r=0.9999,平均回收率99.65%,RSD为1.19%,最低检测限为0.1μg.此法简便、专属、准确,可同时进行含量测定与杂质检查

【Abstract】 This paper is to report a new method for separation of α、β isomer in anordrin and assay of α-isomer in drug material by Zorbax ODS C18 column ,using hydroxyprogesterone caproate as the internal standard,a mixture of acetonitrile-water(90∶10) as the mobile phase.Wavelength of the detector was 208nm. The linear correlation was observed from the concentrations of 2 to 12μg(r=09999).The average recovery was(9965±119)%.The detection limit was 01μg.The method was convenient,selective and accurate.Anordrin and its impurities can be determined simultaneously.

【关键词】 双炔失碳酯反相高效液相色谱法
【Key words】 anordrinRP-HPLC
  • 【文献出处】 药物分析杂志 ,CHINESE JOURNAL OF PHARMACEUTICAL ANALYSIS , 编辑部邮箱 ,1998年01期
  • 【分类号】R927.2
  • 【被引频次】1
  • 【下载频次】57
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