HPLC法测定维生素A棕榈酸酯原料药中主成分及有关物质含量  

Determination of the Content of Vitamin A Palmitate and Its Related Substances by HPLC

作　　者：刘爱[1] 唐小海[1,2,3] 谢永美[1] 霍晓方[1] 杨丹[1] 胡晓[1] 宋航[1] 

机构地区：[1]四川大学制药与生物工程系,成都市610065 [2]重庆莱美药业股份有限公司,重庆市401336 [3]四川省肿瘤医院,成都市610041

出　　处：《中国药房》2009年第25期1978-1979,共2页China Pharmacy

摘　　要：目的:建立以高效液相色谱法测定维生素A棕榈酸酯原料药中主成分及有关物质含量的方法。方法:色谱柱为Phenomenex Luna C18,流动相为乙腈-异丙醇(90∶10),检测波长为328nm,柱温为30℃,流速为1.0mL·min-1。结果:主成分峰与各杂质峰分离良好,维生素A棕榈酸酯检测浓度的线性范围为90～400mg·L-1(r=0.9992);平均加样回收率为99.60%(RSD=1.32%);有关物质平均含量<2.53%。结论:本方法简便、准确、专属性好,可用于该原料药的质量控制。OBJECTIVE： To establishment the method for the determination of content of vitamin A palmitate（VAP） and its related substances by HPLC. METHODS： The HPLC conditions were consisted of Phenomenex Luna Cls column with a mobile phase of a mixture of acetonitrile-isopropanol （90 ： 10） , the detection wavelength of 328 nm,the column temperature of 30℃ and the flow rate of 1.0mL·min^-1. RESULTS： VAP was completely separated from impurities, the linearity range was 90-400mg·L^-1（r = 0.9992） . The average recovery rate was 99.60% （RSD = 1.32% ） . The average content of the related substances were lower than 2.53% . CONCLUSION： This accurate and reliable HPLC method is applicable for the quality control of VAP.

关 键 词：高效液相色谱法 维生素A棕榈酸酯 有关物质 含量 

分 类 号：R927.2[医药卫生—药学] R977.2