辅酶Q10在正己烷溶液中的稳定性研究

Study on stability of coenzyme Q10 in n-hexane solution

目的考察辅酶Q10在其异构体检测配制的正己烷溶液中的稳定性情况。方法参考《美国药典》、《欧洲药典》、《中国药典》2010年版等法定标准要求的辅酶Q10原料异构体检测方法,最终采用《中国药典》方法,选取5批,3个不同来源的辅酶Q10产品,分别将异构体检测溶液置于棕色量瓶和透明量瓶中,放置0、3、5 h,对比异构体检测HPLC图谱各杂质峰面积归一化百分比的变化情况。结果该研究通过一系列试验证实了异构体检测溶液在存放过程会发生降解,从而导致检测结果的偏差。结论辅酶Q10异构体检测样品溶液配制必须临用新配,避光操作。

Objective To study the stability ofcoenzyme Q10 （CoQ10） in the isomer test solution. Methods Based on the CoQ10 isomer test method in USP, EP, and Chinese Pharmacopoeia 2010 （ChP2010）, the method in ChP2010 is finally used. Five batches of CoQ10 products from three different sources were selected, and the difference of chromatogram area percentage on different storage conditions （brown and transparent flasks） and different storage time （0, 3, and 5 h） were compared. Conclusion This study proves that CoQ10 is gradually decomposed in isomer test solution by testing campaign, which results in the deviation of detection. The test solution must be prepared before use and operated away from light.