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非诺贝酸有关物质的HPLC法测定
引用本文:陆步实,侯敬文,杨大龙,王静,卢定强. 非诺贝酸有关物质的HPLC法测定[J]. 中国医药工业杂志, 2012, 43(5): 372-374
作者姓名:陆步实  侯敬文  杨大龙  王静  卢定强
作者单位:1. 南京工业大学江苏省药物研究所有限公司,江苏南京,210009
2. 南京工业大学药学院,江苏南京,210009
摘    要:
建立了高效液相色谱法测定非诺贝酸的有关物质.以苯基硅烷键合硅胶为填充剂,流动相为乙腈-10 mmol/L磷酸二氢钾溶液(1∶1,用磷酸调至pH 2.5),检测波长289 nm.非诺贝酸的最低检测限为1 ng,关键中间体和破坏性试验产生的降解产物和非诺贝酸均能有效分离.

关 键 词:非诺贝酸  有关物质  高效液相色谱  测定

Determination of Related Substances in Fenofibric Acid by HPLC
LU Bushi , HOU Jingwen , YANG Dalong , WANG Jing , LU Dingqiang. Determination of Related Substances in Fenofibric Acid by HPLC[J]. , 2012, 43(5): 372-374
Authors:LU Bushi    HOU Jingwen    YANG Dalong    WANG Jing    LU Dingqiang
Affiliation:1(1.Jiangsu Provincial Institute of Material Medica,Nanjing University of Technology,Nanjing 210009; 2.School of Pharmaceutical Sciences,Nanjing University of Technology,Nanjing 210009)
Abstract:
An HPLC method was established for the determination of the related substances in fenofibric acid.A phenyl column was used with the mobile phase of acetonitrile-10 mmol/L potassium dihydrogen phosphate solution (1︰1,adjusted to pH 2.5 with phosphoric acid) at the detection wavelength of 289 nm.The low limit of detection was 1 ng.The key intermediate and degradation products generated by destructive experiments could be separated effectively with fenofibric acid.
Keywords:fenofibric acid  related substance  HPLC  determination
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