HPLC-ELSD法测定卵磷脂片中的磷脂酰乙醇胺和蛋黄磷脂酰胆碱
Determination of Phosphatidyl Ethanolamine and Egg Yolk Phosphatidylcholine in Lecithin Tablets by HPLC-ELSD
吴盼盼 1王春贺 1姜晓菊 1岳云飞 1王常禹1
作者信息
- 1. 黑龙江省药品检验研究院,黑龙江哈尔滨 150088
- 折叠
摘要
建立了 HPLC-ELSD法测定卵磷脂(1)片中的磷脂酰乙醇胺(2)和蛋黄磷脂酰胆碱(3).采用CAPCELL PAK C18色谱柱(4.6mm×250mm,5 μm),以甲醇、水、冰乙酸和三乙胺(体积比85∶15∶0.45∶0.05)为流动相A,以正己烷、异丙醇和流动相A(体积比20∶48∶32)为流动相B,梯度洗脱.结果显示,2、3分别在2～50和20～400μg/mL内线性关系良好,平均加样回收率(n=6)分别为102.9％和106.6％,RSD分别为2.6％和1.4％.含量测定结果显示,6批1片中,2和3的含量分别为每片1.5～5.0和40.0～65.0 mg.建立的方法具有良好的专属性、准确性,可用于1片中2和3的测定.
Abstract
An HPLC-ELSD method was established to determine the contents of phosphatidyl ethanolamine(2)and egg yolk phosphatidylcholine(3)in lecithin(1)tablets.The CAPCELL PAK C18 column(4.6 mm×250 mm,5 μm)was used,and the analysis was carried out in the gradient elution mode with methanol-water-glacial acetic acid-triethylamine(85∶15∶0.45∶0.05)as mobile phase A,and n-hexane-isopropanol-mobile phase A(20∶48∶32)as mobile phase B.The results showed that it was linear for 2 and 3 in the ranges of 2-50 and 20-400 μg/mL,respectively.The average recoveries(n=6)of 2 and 3 were 102.9％and 106.6％,respectively,with RSDs of 2.6％and 1.4％.The content determination results showed that in six batches of 1 tablets,the contents of 2 and 3 were 1.5-5.0 and 40.0-65.0 mg per tablet,respectively.The established method has good specificity and accuracy,which can be used for the determination of 2 and 3 in 1 tablets.
关键词
卵磷脂片/磷脂酰乙醇胺/蛋黄磷脂酰胆碱/HPLC-ELSD/含量测定Key words
lecithin tablet/phosphatidyl ethanolamine/egg yolk phosphatidylcholine/HPLC-ELSD/content determination引用本文复制引用
基金项目
国家药典委员会药品标准提高项目(2017)(食药监办药化管[2017]139号)
出版年
2024
NETL
NSTL
万方数据