RT-HPLC detecting method of relevant matters of sodium gualenate

The invention relates to the technical field of drug analysis, and discloses a RT-HPLC detecting method of relevant matters of sodium gualenate. The detecting method includes steps of configuring analysis solution; chromatographic condition; online detection. At present, there is no related complete...

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Hauptverfasser: TAO JINLAI, ZHAO QING, HUO LIRU, LI ZHAN, XIONG RUJU, DENG SHULAN
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention relates to the technical field of drug analysis, and discloses a RT-HPLC detecting method of relevant matters of sodium gualenate. The detecting method includes steps of configuring analysis solution; chromatographic condition; online detection. At present, there is no related complete patent and literature report about the detecting method of the relevant matters of sodium gualenate. The method can effectively detect the existence of various related impurities in relevant matters of sodium gualenate, particularly realize the characteristic peak of sodium gualenate and the characteristic peak of its isomer in a spectrogram, and realize the separation of characteristic peak of sodium gualenate and the characteristic peak of multiple degrading impurities in a spectrogram, thereby guaranteeing controllable quality of the product. 本发明涉及药物分析技术领域,公开了种薁磺酸钠有关物质的RT-HPLC检测方法,包括下列步骤:配置分析溶液;色谱条件;上机测定。目前,暂没关于薁磺酸钠有关物质检测方法的相关完整的专利及文献报道。本发明能够有效的测定薁磺酸钠中各种相关杂质存在,尤其不仅实现了谱图中薁磺酸钠特征峰与其异构体特征峰,而且实现谱图中薁磺酸钠特征峰与较多降解杂质特征峰的