高效液相色谱法同时测定维胺酯维E乳膏中维胺酯和维生素E的含量  

Simultaneous Determination of Viaminate and Vitamin E in Viaminate and Vitamin E Cream by HPLC

作　　者：李晓燕 李钰鑫 李侯 唐浩铮 兰文 谢莹莹 范蕾 刘雁鸣 扈麟 Li Xiaoyan;Li Yuxin;Li Hou;Tang Haozheng;Lan Wen;Xie Yingying;Fan Lei;Liu Yanming;Hu Lin(Hunan Drug Inspection Center,Changsha 410001,China;Hunan Institute for Drug Control and Texting,Changsha 410001,China;South China University of Technology,Guangzhou 510641,China)

机构地区：[1]湖南省药品审核查验中心,湖南长沙410001 [2]湖南省药品检验检测研究院,湖南长沙410001 [3]华南理工大学,广东广州510641

出　　处：《广东化工》2024年第15期140-142,115,共4页Guangdong Chemical Industry

基　　金：湖南省科药联合基金项目:维胺酯原料及胶囊质量标准提高研究(2021JJ80035)。

摘　　要：目的:建立一种采用梯度洗脱的高效液相色谱法,同时分析维胺酯维E乳膏中维胺酯和维生素E的含量。方法:采用色谱柱:C18柱,Agilent Eclipse XDB(250 mm×4.6 mm,5μm),以甲醇(A)与水(B)为流动相,梯度洗脱,1.0 mL/min流速,25℃柱温,20μL进样体积,285 nm检测波长。结果:维胺酯与光降解杂质、维生素E与相邻杂质均能有效分离,维胺酯与维生素E的浓度在相应的范围内与峰面积呈良好线性关系(r均>0.9999);维胺酯与维生素E的平均加样回收率分别为99.65%、RSD=0.62%与99.63%、RSD=0.60%,精密度、稳定性良好。维胺酯维E乳膏(3个企业共5批次样品)中维胺酯与维生素E的含量均在标示量92.5%~103.6%之间。结论:该方法专属性好,简便快捷准确,可用于维胺酯维E乳膏的质量控制。Objective:A method for simultaneously determining Viaminate and Vitamin E in Viaminate and Vitamin E Cream by High performance liquid chromatography gradient elution was established.Methods:Separation was performed on a Agilent Eclipse XDB C18 column(250 mm×4.6 mm×5μm)and the mobile phase was methanol-water with gradient elution at a flow rate of 1.0 mL/min.The detective wavelength was set at 285 nm and the column temperature was 25℃.The injection volume was 20μL.Results:Good separation of Viaminate and the related substances,Vitamin E and the related substances both was achieved.Viaminate and Vitamin E had a good linear relationship in their concentration ranges(r>0.9999),The average recovery was 100.75%(RSD=0.61%),99.63%(RSD=0.60%),respectively.Good precision and stability both was achieved.The content of Viaminate and Vitamin E in vitamin E cream(5 batches of samples from 3 companies)is between 92.5%and 103.6%of the labeled amount.Conclusion:This method is specific,simple,fast,and accurate.It can be used for quality control of vitamin E cream.

关 键 词：维胺酯维E乳膏 维胺酯 维生素E 高效液相色谱法 梯度洗脱 质量控制 

分 类 号：TQ[化学工程]