| HPLC检查非布司他原料药中的有关物质 |
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| 引用本文： | 崔婷,张露,戴光琴,张道林,蒋心惠.HPLC检查非布司他原料药中的有关物质[J].华西药学杂志,2017,32(2). |
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| 作者姓名： | 崔婷 张露 戴光琴 张道林 蒋心惠 |
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| 作者单位： | 1. 重庆医科大学药学院,重庆,400016;2. 四川大学华西医院,四川成都,610041;3. 巫山县人民医院,重庆,404700;4. 重庆医药工业研究院有限责任公司,重庆,400061 |
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| 摘 要： | 目的 采用HPLC法测定Febuxostat原料药中的有关物质.方法 采用Agilent Eclipse plus C18色谱柱,以0.05％磷酸溶液-乙腈(40∶60)为流动相,检测波长220 nm,流速1.0 mL· min-1,柱温40℃.结果 在建立的色谱条件下,Febuxostat与其有关物质的分离良好(R＞1.5),杂质A、B、C的相对校正因子分别为1.344、1.588、2.157.结论 所用方法操作简便、灵敏度高、专属性强,可用于Febuxostat中有关物质的检查.
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| 关 键 词： | 非布司他 高效液相色谱 有关物质 原料药 检查 相对校正因子 相对保留时间 紫外检测器 |
Determination of the related impurities in Febuxostat by HPLC |
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| CUI Ting,ZHANG Lu,DAI Guangqin,ZHANG Daolin,JIANG Xinhui.Determination of the related impurities in Febuxostat by HPLC[J].West China Journal of Pharmaceutical Sciences,2017,32(2). |
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| Authors: | CUI Ting ZHANG Lu DAI Guangqin ZHANG Daolin JIANG Xinhui |
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| Abstract: | OBJECTIVE To determin the related substances in Febuxostat by HPLC.METHODS An Agilent Eclipse plus C18 column(250 mm × 4.6 mm,5 μm) was used with a mobile phase consisting of 0.05 ％ phosphoric acid-acetonitrile (40 ∶ 60) at the flow rate of 1.0 mL· min-1.The detection wavelength was 220 nm,and the temperature was 40 ℃.RESULTS Under the optimum condition,the Febuxostat and its related substances could be separated well.The relative correction factors of impurities A,B and C with Febuxostat were 1.344,1.588 and 2.157,respectively.CONCLUSION The established method is sensitive,effective,reproducible and easy to handle,which can be used for the determinating of the related substances in Febuxostat. |
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| Keywords: | Febuxostat HPLC Related impurities Crude drugs Test Relative correction factors Relative retantion time UVD |
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