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盐酸非索非那定杂质的LC-MS检测及结构鉴定

Determination of Impurities in Fexofenadine Hydrochloride by LC-MS

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【作者】 彭锋安穗伟梁北梅王玉平林丽薇

【Author】 PENG Feng,AN Sui-wei,LIANG Bei-mei,WANG Yu-ping,LIN Li-wei (Guangzhou Institute of Pharmaceutical&Industry,Guangzhou 510240)

【机构】 广州市医药工业研究所

【摘要】 分别用HPLC和LC-MS法分析抗过敏药物盐酸非索非那定两年长期留存样品的杂质变化情况。结果发现3个杂质,主要杂质为α,α-二甲基-4-[4-[4-(羟基二苯甲基)-1-哌啶基]-1-氧代丁基]苯乙酸,两年留样后含量增加了1.53%;其余两个杂质为α,α-二甲基-4-[1-羟基-4-[4-(羟基二苯甲基)-1-哌啶基]丁基]苯乙酸甲酯和α,α-二甲基-4-[1-羟基-4-[4-(羟基二苯甲基)-1-哌啶基]丁基]苯乙酸丁酯,含量基本不变。

【Abstract】 The HPLC and LC-MS methods were used respectively to identify the impurities of anti-allergy agent fexofenadine hydrochlorideafter two years’storage.Three impurities were found and their structures were confirmed;the main impurity isα,α-dimethyl-4-[4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]-1-oxobutyl]benzeneacetic acid,whose content increased 1.53%.The others are methylα,α-dimethyl-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin1-yl]butyl]benzeneacetate and butylα,α-dimethyl-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1yl]butyl]benzeneacetate,whose content did not changed significantly during storage.

【关键词】 非索非那定杂质液相色谱-质谱联用测定
【Key words】 fexofenadineimpurityLC-MSdetermination
  • 【文献出处】 中国医药工业杂志 ,Chinese Journal of Pharmaceuticals , 编辑部邮箱 ,2009年08期
  • 【分类号】R927.2
  • 【被引频次】5
  • 【下载频次】242
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