摘要
目的建立高效液相色谱法测定7种肠外营养制剂脂肪乳注射液中溶血磷脂酰胆碱(lysophosphatidylcholine,LPC)和溶血磷脂酰乙醇胺(lysophosphatidylethanolamine,LPE)含量的方法。方法样品经色谱柱Xbridge BEH HILIC(250 mm×4.6 mm,5μm)分离,以甲醇-水-冰醋酸-三乙胺(85:15:0.5:0.05,V:V:V:V)与正己烷-异丙醇(20:48,V:V)为流动相进行梯度洗脱,标准曲线法定量。结果在选定条件下,LPC和LPE与样品中其他组分分离良好;二者峰面积的对数与浓度的对数均呈良好的线性关系,LPC和LPE的线性范围分别为0.02~0.20 mg/mL(r=0.9998)和0.01~0.10 mg/mL(r=0.9997);LPC和LPE的定量限分别为5、10μg/mL;平均回收率分别99.77%~101.03%和102.30%~103.06%,相对标准偏差均小于2.0%。结论该方法效率高、准确性好,适用于7种肠外营养制剂脂肪乳注射液中LPC和LPE的测定。
Objective To establish a method for the determination of lysophosphatidylcholine(LPC)and lysophosphatidylethanolamine(LPE)in 7 kinds of parenteral nutrition preparation fat emulsion injection by high performance liquid chromatography.Methods The samples were separated by Xbridge BEH HILIC column(250 mm×4.6 mm,5μm)using methanol-water-glacial acetic-triethylamine(85:15:0.5:0.05,V:V:V:V)and n-hexan-isopropanol(20:48,V:V)as the mobile phase for gradient elution,and quantitated by standard curve method.Results Under selected conditions,LPC and LPE were well separated from other components in the sample.There was a good linear relationship between the logarithm of the peak area and the logarithm of the concentration.The linear ranges of LPC and LPE were 0.02-0.20 mg/mL(r=0.9998)and 0.01-0.10 mg/mL(r=0.9997),respectively.The limits of quantitation for LPC and LPE were 5 and 10μg/mL,respectively.The average recoveries were 99.77%‒101.03%and 102.30%‒103.06%,respectively,and the relative standard deviations were all less than 2.0%.Conclusion The method is efficient,accurate and suitable for the determination of LPC and LPE in 7 kinds of parenteral nutrition preparation fat emulsion injection.
作者
谭梦茹
申兰慧
王丽
葛晓莹
杨敏智
TAN Meng-Ru;SHEN Lan-Hui;WANG Li;GE Xiao-Ying;YANG Min-Zhi(Wuxi Center for Drug Safety Control,Wuxi 214000,China)
出处
《实验室检测》
2023年第5期8-13,共6页
Laboratory Testing
基金
江苏省市场监督管理局科技计划项目(KJ2022029)
关键词
肠外营养制剂
脂肪乳注射液
溶血磷脂酰胆碱
溶血磷脂酰乙醇胺
高效液相色谱法
parenteral nutrition preparation
fat emulsion injection
lysophosphatidylcholine
lysophosphatidylethanolamine
high performance liquid chromatography
作者简介
通信作者:谭梦茹,主管药师,主要研究方向为药物分析。E-mail:tiantan1289@sina.com
