HPLC法测定维生素AD微丸中维生素A棕榈酸酯的有关物质  

Determination of related substance of vitamin A palmitate in vitamin AD pellets by HPLC

作　　者：周远华[1] 陈静[1] 张立雯[1] 董顺玲[1] ZHOU Yuanhua;CHEN Jing;ZHANG Liwen;DONG Shunling(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国药品标准》2022年第1期40-45,共6页Drug Standards of China

摘　　要：目的:建立两个高效液相色谱法测定维生素AD微丸中维生素A棕榈酸酯的有关物质。方法:采用Phenomenex Luna NH_(2)色谱柱(4.6 mm×250 mm,3μm),以正己烷为流动相,检测波长325 nm,以主成分外标法测定维生素A棕榈酸酯顺式异构体;采用Waters SunFire(4.6 mm×250 mm,5μm)色谱柱,以甲醇-水(99∶1)和甲醇为流动相,梯度洗脱,检测波长305 nm,以外标法测定其他有关物质。结果:正相色谱法中,检测限和定量限分别为0.015 IU·mL^(-1)和0.051 IU·mL^(-1),顺式异构体为5.8%~6.5%;反相色谱法中,检测限和定量限分别为0.28 IU·mL^(-1)和0.93 IU·mL^(-1),单个最大杂质为0.8%~0.9%,总杂质为2.2%~2.6%。结论:本实验建立的分析方法能够测定维生素A棕榈酸酯的顺式异构体和其他有关物质,方法专属性强、灵敏度高,可用于控制维生素AD微丸中维生素A棕榈酸酯的质量。Objective:To establish two HPLC methods for determination of related substance of vitamin A palmi-tate in vitamin AD pellets.Methods:The test was performed in Phenomenex Luna NH_(2)column(4.6 mm×250mm,5μm)under the elution of n-hexane with the detection wavelength as 325 nm for cis-vitamin A palmitate.The content of cis-vitamin A palmitate was calculated by HPLC-external standard method using principal componentas the reference.The test was performed in Waters SunFire(4.6 mm×250 mm,5μm)under the gradient elution ofmethanol-water(99∶1)and water with detection wavelength of 305 nm for other impurities.The mobile phase weregradient eluting with methanol-water(99∶1)and methanol.The contents of other impurities were calculated byHPLC-external standard method.Results:In NP-HPLC method,the limits of detection and quantification were0.015 and 0.051 IU·mL^(-1)respectively,and the content of cis-vitamin A palmitate was 5.8%-6.5%.In RP-HPLC method,the limits of detection and quantification were 0.28 IU·mL^(-1)and 0.93 IU·mL^(-1)respectively,thesingle maximum impurity was 0.8%-0.9%and total impurities was 2.2%-2.6%.Conclusion:The established HPLC methods can determine cis-vitamin A palmitate and other impurities.These methods have the good specificityand sensitivity,and can be applicable to quality control of vitamin A palmitate in vitamin AD pellets.

关 键 词：维生素A棕榈酸酯 顺式异构体 有关物质 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]