用HPLC法测定珍珠维E乳膏中维生素B_6和维生素E的含量  

Determination of vitamin B_6 and vitamin E contents in Pearl vitamin E cream by HPLC method

作　　者：陈方剑[1] 陆松伟[1] 宋洪杰[1] 高鸿彬[1] 全山丛[1] 骆锦前 

机构地区：[1]第二军医大学长海医院药学部,上海200433

出　　处：《药学服务与研究》2015年第3期201-204,共4页Pharmaceutical Care and Research

基　　金：总后勤部卫生部军队医疗机构制剂标准提高科研专项(13ZJZ11-3)

摘　　要：目的：建立HPLC法测定珍珠维E乳膏中维生素B6和维生素E的含量。方法：维生素B6：Kromasil C18色谱柱（150mm×4.6mm,5μm）;流动相：甲醇-0.04%庚烷磺酸钠（用冰乙酸调节pH至3.0）=20∶80;检测波长：291nm。维生素E：ACE-121-1546C18色谱柱（150mm×4.6mm,5μm）;流动相：甲醇-水=95∶5,检测波长：285nm。流速：1.0ml/min;柱温：室温。结果：维生素B6在5.000 5-100.01μg/ml范围内线性关系良好（r=1.000 0）,低、中、高浓度（标示量80%、100%、120%）的平均回收率分别为（97.46±1.30）%、（99.00±0.34）%、（98.09±0.56）%（n=3）。维生素E在31.96-255.68μg/ml范围内线性关系良好（r=0.999 9）,低、中、高浓度（标示量80%、100%、120%）的平均回收率分别为（100.04±1.57）%、（100.02±0.30）%、（102.92±0.56）%（n=3）。精密度、重现性和稳定性良好。结论：该方法准确、灵敏,专属性强,重现性好,对珍珠维E乳膏质量控制标准的提高具有参考意义。Objective：To establish a HPLC method for the determination of vitamin B6 and vitamin E contents in Pearl vitamin E cream.Methods：The separation of vitamin B6 was performed on Kromasil C18column（150mm×4.6mm,5μm）.The mobile phase was composed of methanol-0.04% sodium heptane sulfonic solution（pH adjusted to 3.0with glacial acetic acid,20∶80）and the detection wavelength was 291 nm.The separation of vitamin E was performed on ACE-121-1546C18column（150mm×4.6mm,5μm）.The mobile phase was composed of methanol-water（95∶5）and the detection wavelength was285 nm.The flow rate of the mobile phase was 1.0ml/min and the column temperature was set at room temperature.Results：Vitamin B6 was in good linearity within the range of 5.000 5-100.01μg/ml（r=1.000 0）.The average recoveries of low,moderate and high concentrations（80%,100%,120% of the labeled content）were（97.46±1.30）%,（99.00±0.34）%and（98.09±0.56）%（n=3）,respectively.Vitamin E was in good linearity within the range of 31.96-255.68μg/ml（r=0.999 9）.The average recoveries of low,moderate and high concentrations（80%,100%,120% of the labeled content）were（100.04±1.57）%,（100.02±0.30）% and（102.92±0.56）%（n=3）,respectively.Conclusion：The method is accurate,sensitive,selective and reproducible.It can provide reference for the improvement of the quality standard of Pearl vitamin E cream.

关 键 词：珍珠维E乳膏 维生素B6 维生素E 含量测定 色谱法 高效液相 

分 类 号：R972.2[医药卫生—药品]