Method for detecting suspected genotoxic impurities in febuxostat tablets

The invention discloses a method for detecting suspected genotoxic impurities in febuxostat tablets, which comprises the following steps: detecting a febuxostat tablet test solution or a resolution solution by using a phenyl bonded silica gel chromatographic column as a stationary phase and adopting...

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Hauptverfasser: CHEN SHAOBO, SHI HUIMIN, LIANG YINXING, LAN YONGFENG, WU RUCHAO
Format: Patent
Sprache:chi ; eng
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Beschreibung
Zusammenfassung:The invention discloses a method for detecting suspected genotoxic impurities in febuxostat tablets, which comprises the following steps: detecting a febuxostat tablet test solution or a resolution solution by using a phenyl bonded silica gel chromatographic column as a stationary phase and adopting high performance liquid chromatography, the detection conditions are as follows: the mobile phase comprises a mobile phase A and a mobile phase B; the mobile phase A is an acidic solution; the mobile phase B comprises at least one of acetonitrile, methanol and ethanol; a gradient elution procedure is adopted in the detection process of the high performance liquid chromatography, and the volume ratio of the mobile phase A to the mobile phase B is (0-80): (20-100). The method disclosed by the invention has the advantages of high efficiency, high sensitivity and high accuracy, and IMP-07 can be quickly and accurately detected. 本发明公开了一种检测非布司他片中疑似基因毒性杂质的方法,包括以下步骤:将非布司他片供试品溶液或者分离度溶液以苯基键合硅胶色谱柱为固定相,采用高效液相色谱进行检测;检测条件包括:流动相