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伏立诺他有关物质的HPLC法测定
Determination of Related Substances in Vorinostat by HPLC
【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C18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。
【Abstract】 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.
- 【文献出处】 中国医药工业杂志 ,Chinese Journal of Pharmaceuticals , 编辑部邮箱 ,2011年10期
- 【分类号】R927;O657.72
- 【被引频次】3
- 【下载频次】237