Method for detecting oxidation impurities in lipoic acid soft capsule

The invention belongs to the technical field of drug detection and analysis, and provides a method for detecting oxidation impurities in lipoic acid soft capsules. The detection method comprises the following steps: preparing each solution, determining chromatographic conditions and recording a chro...

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Hauptverfasser: JIA YUEYING, SUN BO, JIANG ZHOUYU
Format: Patent
Sprache:chi ; eng
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Beschreibung
Zusammenfassung:The invention belongs to the technical field of drug detection and analysis, and provides a method for detecting oxidation impurities in lipoic acid soft capsules. The detection method comprises the following steps: preparing each solution, determining chromatographic conditions and recording a chromatogram by using a liquid chromatograph. The detection method can effectively and comprehensively detect oxidation impurities A-E and lipoic acid amide impurities in the lipoic acid soft capsule, the separation degree between oxidation impurity peaks is high, and the content of each oxidation impurity can be accurately analyzed. 本发明属于药品检测分析技术领域,本发明提供了一种硫辛酸软胶囊中氧化杂质的检测方法。该检测方法包括各个溶液的配制,色谱条件的确定以及使用液相色谱仪记录色谱图;该检测方法可以有效全面的检测硫辛酸软胶囊中氧化杂质A~氧化杂质E和硫辛酸酰胺杂质,且各个氧化杂质峰之间分离度高,可精确分析各个氧化杂质的含量。