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和溶血磷脂酰乙醇胺含量  

Determination of lysophosphatidylcholine and lysophosphatidylethanolamine in 7 kinds of parenteral nutrition preparation fat emulsion injection by high performance liquid chromatography

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)

机构地区：[1]无锡市药品安全检验检测中心,无锡214000

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)

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.

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 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]