氟他胺的稳定性研究(1)
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[摘要] 目的：研究氟他胺在高温、光照、酸性、碱性和氧化条件下可能发生的降解。方法：根据欧洲药典5.0(EP5.0)中氟他胺有关化合物的HPLC测定方法，以百分面积法计算主成分含量和杂质含量。结果：氟他胺在碱性条件下非常容易发生降解，在氧化条件和酸性条件下也会发生降解，在高温和光照条件下相对比较稳定。结论：EP5.0氟他胺相关物质的分析方法具有稳定性、指示性，能分离和检测到产品中可能产生的降解产物。
[关键词] 氟他胺；降解；有关物质
[中图分类号]R913 [文献标识码]A [文章编号]1673-7210(2008)02(b)-027-03
Study on the stability of flutamide
HUANG Dong,LI Qing-hua
(Jiangsu Tasly Diyi Pharmaceutical Co. Ltd., Huaian 223002,China)
[Abstract] Objective:To study the probable degradation of flutamide under the condition of light, heat, acid, alkalic and oxidation,and to evaluate the ability of the analytical method to separate degradation products.Methods: HPLC method of related compounds of flutamide in EP5.0 was used and flutamide and impurity contents were calculated by percentage area method. Results:Flutamide degraded very easily under the alkalic condition, partly degraded under the acid and oxidation conditions, and was stable comparatively under the heat and light conditions ......
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