离子抑制色谱法测定复方氨基酸注射液(18AA-V)中木糖醇的含量  

Determination of xylitol in compound amino acid injection(18AA-V)by ion-suppression chromatography

作　　者：肖菁 左利民[2] 谷永升 赵婷 连晓芳 刘惠一 王蓉蓉 周怡[4] 山广志[2] XIAO Jing;ZUO Li-min;GU Yong-sheng;ZHAO Ting;LIAN Xiao-fang;LIU Hui-yi;WANG Rong-rong;ZHOU Yi;SHAN Guang-zhi(Hunan Institute for Drug Control,Changsha 410001;Institute of Medicinal Biotechnology,Chinese Academy of Medical Sciences,Beijing 100050;College of Pharmacy,Xinjiang Medical University,Urumqi 830017;Chinese Pharmacopoeia Commission,Beijing 100061)

机构地区：[1]湖南省药品检验检测研究院,长沙410001 [2]中国医学科学院医药生物技术研究所,北京100050 [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：《中南药学》2024年第10期2754-2757,共4页Central South Pharmacy

基　　金：湖南省自然科学基金部门(省药监局)联合基金(No.2022JJ80071);国家药典委员会2024年标准制修订课题。

摘　　要：目的建立离子抑制色谱法测定复方氨基酸注射液(18AA-V)中木糖醇的含量。方法采用HyperREZ XP Carbohydrate H+色谱柱(7.7 mm×300 mm,8μm),以12.5×10^(-3) mol·L^(-1)硫酸溶液为流动相,等度洗脱,流速为0.5 mL·min-1,柱温为55℃,检测波长为200 nm。结果木糖醇峰和相邻色谱峰分离度良好,在5.002~20.01 mg·mL^(-1)内与峰面积线性良好(r=0.9997,n=5),精密度、重复性、稳定性试验的RSD均<1.0%,低、中、高浓度的回收率分别为99.10%、97.86%和96.82%,RSD分别为1.9%、1.7%和0.5%(n=3)。3批复方氨基酸注射液(18AA-V)中木糖醇含量分别为标示量的96.96%、97.25%、97.32%。结论该方法可有效解决氨基酸成分的干扰,快速简便、专属性强、准确度高,可用于复方氨基酸注射液(18AA-V)中木糖醇的含量测定。Objective To determine xylitol in compound amino acid injection(18AA-V)by ion-suppression chromatography method.Methods A HyperREZ XP Carbohydrate H+column(7.7 mm×300 mm,8μm)was used,with 12.5×10^(-3)mol·L^(-1)sulfuric acid as the mobile phase,isocratic elution at a flow rate of 0.5 mL·min-1,with the column temperature of 55℃,and detection wavelength of 200 nm.Results The xylitol peak and the adjacent peaks were well separated,with good linearity(r=0.9997,n=5)at 5.002~20.01 mg·mL^(-1).The RSDs of precision,reproducibility,and stability were all<1.0%,The recovery of low,medium,and high concentrations were 99.10%,97.86%,and 96.82%,respectively,with RSDs of 1.9%,1.7%,and 0.5%,respectively(n=3).The content of xylitol in three batches of compound amino acid injection(18AA-V)was 96.96%,97.25%and 97.32%respectively of the labeled amount.Conclusion The method can effectively reduce the interference of amino acid components rapidly and simply,with high specificity and accuracy,and can be used for the content determination of xylitol in compound amino acid injection(18AA-V).

关 键 词：离子抑制色谱法 复方氨基酸注射液(18AA-V) 木糖醇 含量测定 

分 类 号：R927[医药卫生—药学]