| 伏立诺他有关物质的HPLC法测定 |
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| 引用本文： | 邵秀芬,胡雅芳,任建强,王万青.伏立诺他有关物质的HPLC法测定[J].中国医药工业杂志,2011,42(10). |
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| 作者姓名： | 邵秀芬 胡雅芳 任建强 王万青 |
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| 作者单位： | 杭州容立医药科技有限公司,浙江杭州,310023 |
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| 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C1s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.
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| 关 键 词： | 伏立诺他:有关物质 高效液相色谱:测定 |
Determination of Related Substances in Vorinostat by HPLC |
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| Authors: | SHAO Xiufen HU Yafang REN Jianqiang WANG Wanqing |
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| Institution: | SHAO Xiufen,HU Yafang,REN Jianqiang,WANG Wanqing (Hangzhou SFFT Developing Co.,Ltd.,Hangzhou 310023) |
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| Abstract: | An HPLC method was established for the separation and determination of vorinostat and its related substances.A C_(18) 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. |
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| Keywords: | vorinostat related substance HPLC determination |
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