高效离子排斥色谱法检测复方氨基酸注射液(18AA)中山梨醇含量  

Determination of sorbitol content in compound amino acid injection(18AA)using high performance ion-exclusion chromatography

作　　者：左利民[1] 肖菁 郭鑫 赵婷 连晓芳 刘惠一 谷永升 周怡[4] 山广志[1] ZUO Li-min;XIAO Jing;GUO Xin;ZHAO Ting;LIAN Xiao-fang;LIU Hui-yi;GU Yong-sheng;ZHOU Yi;SHAN Guang-zhi(Institute of Medicinal Biotechnology,Chinese Academy of Medical Sciences,Beijing 100050,China;Hunan Institute for Drug Control,Changsha 410001,China;College of Pharmacy,Xinjiang Medical University,Urumqi 830017,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]中国医学科学院医药生物技术研究所,北京100050 [2]湖南省药品检验检测研究院,长沙410001 [3]新疆医科大学药学院,乌鲁木齐830017 [4]国家药典委员会,北京100061

出　　处：《中国新药杂志》2025年第3期312-316,共5页Chinese Journal of New Drugs

基　　金：中国医学科学院医学与健康科技创新工程资助项目(2021-I2M-1-070);国家药典委员会2024年标准制修订课题资助项目(2024H05)。

摘　　要：目的:建立高效离子排斥色谱法测定复方氨基酸注射液(18AA)中山梨醇含量。方法:采用Rezex ROA-organic Acid H^(+)(8%)色谱柱(300 mm×7.8 mm,8μm),流动相为12.5×10^(-3)mol·L^(-1)硫酸溶液,等度洗脱,流速为0.5 mL·min^(-1),柱温为55℃,进样10μL,检测波长200 nm。结果:氨基酸成分不干扰山梨醇测定,山梨醇峰与相邻色谱峰分离度良好,在4.905~19.62 mg·mL^(-1)浓度范围线性良好(r=1.000,n=5),精密度、重复性、稳定性试验的RSD均<1.0%,平均回收率为98.90%,RSD为1.55%(n=9)。3批市售复方氨基酸注射液(18AA)中山梨醇含量分别为标示量的98.54%,97.92%,97.24%。结论:采用该方法能够有效解决氨基酸成分的干扰,不需进行复杂的前处理工作,快速简便、专属性强、准确度高,可用于复方氨基酸注射液(18AA)中山梨醇的含量测定。Objective:To establish a high performance ion-exclusion chromatography method for the determination of sorbitol content in compound amino acid injection(18AA).Methods:A Rezex ROA-organic Acid H^(+)(8%)column(300 mm×7.8 mm,8μm)was used.The mobile phase consisted of 12.5×10^(-3)mol·L^(-1)sulfuric,and isocratic elution was performed at a flow rate of 0.5 mL·min^(-1).The column temperature was maintained at 55℃,with an injection volume of 10μL and a detection wavelength of 200 nm.Results:The amino acid composition did not interfere with the determination of sorbitol,the sorbitol peak and the adjacent peaks were well separated,exhibiting good linearity(r=1.000,n=5)within the concentration range of 4.905~19.62 mg·mL^(-1).The RSDs of precision,reproducibility,and stability tests were all<1.0%,with the average recoveries of 98.90%and RSD of 1.55%(n=9).The contents of sorbitol in 3 batches of commercially available compound amino acid injection(18AA)were 98.54%,97.92%and 97.24%of the labeled amount,respectively.Conclusion:The method can effectively solve the interference from amino acid components,requiring no complicated pretreatment procedures.It is fast and simple,with strong specificity and high accuracy.The method can be used for the determination of sorbitol content in compound amino acid injection(18AA).

关 键 词：高效离子排斥色谱法 复方氨基酸注射液(18AA) 山梨醇 含量测定 

分 类 号：R917[医药卫生—药物分析学]