反相高效液相色谱法测定注射用辅酶Q10冻干乳含量及有关物质

目的建立RP-HPLC法测定辅酶Q10冻干乳含量及有关物质的方法。方法依力特Hypersil BDS C18色谱柱（4.6mm×200mm,5μm）;流动相：甲醇-无水乙醇（55∶45）;柱温：35℃;流速：1.0mL·min^-1;检测波长：275nm;外标法定量,有关物质测定色谱条件与含量测定相同,采用自身对照法计算结果。结果辅酶Q10在50.32～805.12μg·mL^-1线性关系良好（r=0.9999,n=5）,平均回收率为100.3%,RSD为0.99%（n=5）;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,可用于该制剂的含量及有关物质测定。

Determination of coenzyme Q10 in lyophilized emulsion and its related substances by RP-HPLC

Objective To establish an RP-HPLC method for the determination of content and related substances in co-enzyme Q10 in lyophilized emulsion.Methods Analytic column：Elite Hypersil BDS C18（4.6 mm×200 mm,5 μm）;mobile phase：methanol-dehydrated alcohol（55∶45）;detection wavelength：275 nm;temperature：35 ℃;flow rate：1.0 mL·min^-1.The chromatographic conditions of related substances were the same as that of the assay.Results Coenzyme Q10 had a good linear relation at 50.32～805.12 μg·mL^-1（r=0.999 9,n=5）,the average recovery was 100.3%,and RSD was 0.99%（n=5）.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 content and related substances of coenzyme Q10 in lyophilized emulsion.