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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。
Aim To investigate the stability of coenzyme Q10 in the isoparaffin solution of n-hexane. Methods Reference to the United States Pharmacopoeia, “European Pharmacopoeia”, “Chinese Pharmacopoeia” 2010 edition and other statutory standards for coenzyme Q10 raw material isomers detection method, the final use of “Chinese Pharmacopoeia” method, select five batches of three different sources of coenzyme Q10 product, respectively, the isometric detection solution was placed in a brown flask and a transparent volumetric flask, placed 0,3,5 h, comparing isoforms detect HPLC peaks of each impurity peak area normalized percentage change. Results The study, through a series of experiments, confirmed the degradation of the isomeric test solution during storage, resulting in deviations in test results. Conclusion The preparation of coenzyme Q10 isomers must be freshly prepared and protected from light.