辅酶Q10氯化钠注射液有关物质方法的建立及其有关物质稳定性研究

目的建立RP-HPLC法测定辅酶Q10氯化钠注射液有关物质的检查方法 ,并考察样品在贮藏过程中有关物质的变化情况。方法色谱柱：ZORBAXSB-C18（150mm×4.6mm,5μm）;流动相：甲醇-无水乙醇（1∶1）;柱温：35℃;流速：1ml/min;检测波长：275nm。采用自身对照法计算结果。结果辅酶Q10在12.8～816μg/ml线性关系良好（r=0.9993,n=6）;精密度良好,RSD为1.33%（n=7）;回收率为99.47%,RSD为0.71%;辅酶Q10与多种有关物质分离良好,制剂中其他成分不干扰测定。结论该方法准确可靠、简单快速,可用于该制剂有关物质的测定,同时经过稳定性考察本品在避光情况下放置,有关物质变化不大。

Set up the method of related substances in coenzyme Q10 and sodium chloride injection and study on its stability

Objective To establish an RP-HPLC method for the determination of related substances in coenzyme Q10 and sodium chloride injection,and investigate the change of its related substances during the storage period.Methods Analytic column：ZORBAX SB-C18（150mm×4.6mm,5μm）;Mobile phase ：Methanol-dehydrated alcohol（1∶1）;Temperature：35℃;Flow rate：1.0ml/min;Detection wavelength：275nm.Confrontationed with its own calculations.Results Coenye Q10 had a good linear relation at 12.8~816μg/ml（r=0.9993,n=5）;The precision was good,RSD was 1.33%（n=7）;The recovery was 99.47%,RSD was 0.71%.The related substances and coenzyme Q10 were well-separated,and other ingredients of preparation had no interference with the assay.Conclusion This method is simple,accurate,sensitive and applicable for the determination of related substances of coznye Q10 and sodium chloride injection.The injection was storaged in dark,its related substances had no obvious change during the storage period.