HPLC测定复方氨基酸注射液(18AA)有关物质的初步研究  

Preliminary research of an HPLC method for the related substances in compound amino acid injection (18 AA)

作　　者：楼永明 林敏 陈秀琳 LOU Yongming;LIN Ming;CHENG Xiuling(Fujian Institute for Food and Drug Control,Fuzhou 350001,China)

机构地区：[1]福建省食品药品质量检验研究院,福州350001

出　　处：《中国药品标准》2019年第1期37-41,共5页Drug Standards of China

摘　　要：目的:建立复方氨基酸注射液(18AA)中的部分易氧化氨基酸有关物质测定方法。方法:Kromasil苯基键合硅胶柱(4.6 mm×250 mm,5μm),流动相为0.1 mol·L^(-1)醋酸钠-甲醇(90∶10),检测波长为254 nm,进样量10μL。结果:各杂质峰与各主成份峰均可以有效分离,重复性RSD为3.2%,色氨酸的光照及氧化降解对该注射液有关物质影响明显,测定3个药企的不同批次产品,有关物质含量差别较大。结论:方法操作简单,快速,重复性好,为复方氨基酸注射液质量控制提供更有效的方法。Objective:To establish a method to detect impurities from a part of easily oxidized amino acids in compound amino acid injection (18AA).Methods :The HPLC analysis was performed on a Kromasil Phenyl (4.6 mm × 250mm,5 μm)column with the mobile phase of 0.1 mol·L^-1 sodium acetate and methanol (90:10)at a flow rate of 1.0 mL·min^-1 The injection volume was 10 μL.Results:Impurities were completely separated from main components,and RSD values of repeatability were 3.2%.Tryptophan impurities destroyed by oxidation and light were detected in the sample,and the content of impurities in compound amino acid injection (18 AA)from different sources were significantly different.Conclusion:The method was simple,rapid and reproducible,and could be used for the quality control of compound amino acid injection.

关 键 词：复方氨基酸注射液 有关物质 高效液相色谱法 色氨酸 易氧化氨基酸 

分 类 号：R921.2[医药卫生—药学]