Determination of sorbitol content in compound amino acid injection(18AA)using high performance ion-exclusion chromatography
ZUO Li-min
XIAO Jing
GUO Xin
ZHAO Ting
LIAN Xiao-fang
LIU Hui-yi
GU Yong-sheng
ZHOU Yi
SHAN Guang-zhi
Abstract：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,8 μm)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 10 µL 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).
Keywords：high performance ion-exclusion chromatographycompound amino acid injection(18AA)sorbitolcontent determination
Publication Date：2025-02-14
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 312-316 )