非诺贝酸有关物质的HPLC法测定  

Determination of Related Substances in Fenofibric Acid by HPLC

作　　者：陆步实[1] 侯敬文[2] 杨大龙[1] 王静[1] 卢定强[1] 

机构地区：[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

出　　处：《中国医药工业杂志》2012年第5期372-374,共3页Chinese Journal of Pharmaceuticals

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。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.

关 键 词：非诺贝酸 有关物质 高效液相色谱 测定 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]