伏立诺他有关物质的HPLC法测定  

Determination of Related Substances in Vorinostat by HPLC

作　　者：邵秀芬 胡雅芳 任建强 王万青 

机构地区：[1]杭州容立医药科技有限公司,浙江杭州310023

出　　处：《中国医药工业杂志》2011年第10期781-783,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了高效液相色谱法分离并测定伏立诺他中的5种有关物质。采用C_(18)色谱柱,以20 mmol/L磷酸二氢钾溶液(pH 4.6)-乙腈为流动相,进行梯度洗脱,检测波长242 nm。在此条件下,伏立诺他与5种有关物质分离完全。4批伏立诺他原药中总杂质含量为0.40%～0.52%,最大杂质为辛二酸单酰苯胺。An HPLC method was established for the separation and determination of vorinostat and its related substances. A C18 column was used, with the mobile phase of 20 mmol/L potassium dihydrogen phosphate solution （pH 4.6） -acetonitrile by gradient elution, at the detection wavelength of 242 nm. Vorinostat and its five related substances could be separated well. The content of total impurity in four batches of vorinostat was 0.40%-0.52% and the main impurity was 8-oxo-8- （phenylamino） octanoic acid.

关 键 词：伏立诺他 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]