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

作　　者：吴盼盼 王春贺 姜晓菊 岳云飞 王常禹 WU Panpan;WANG Chunhe;JIANG Xiaoju;YUE Yunfei;WANG Changyu(Heilongjiang Institute for Drug Control,Harbin 150088)

机构地区：[1]黑龙江省药品检验研究院,黑龙江哈尔滨150088

出　　处：《中国医药工业杂志》2024年第2期271-274,282,共5页Chinese Journal of Pharmaceuticals

基　　金：2017年度国家药典委员会药品标准提高项目(食药监办药化管[2017]139号)。

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 C_(18)色谱柱(4.6 mm×250 mm,5μm),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。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 C_(18)column(4.6 mm×250 mm,5μm)was used,and the analysis was carried out in the gradient elution mode with methanol-water-glacial acetic acidtriethylamine(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 20-400μg/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 

分 类 号：R917[医药卫生—药物分析学]