复方醋酸钠林格注射液中无水葡萄糖含量测定方法的建立及葡萄糖转化现象的探讨  

Determination of anhydrous glucose in compound sodium acetate ringers injection and discussion of glucose transformation in products

作　　者：章娟[1] 石颖 邱娟[1] 李玮玲[1] ZHANG Juan;SHI Ying;QIU Juan;LI Weiing(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《广东药科大学学报》2023年第4期14-19,共6页Journal of Guangdong Pharmaceutical University

基　　金：广州市市场监督管理局科技项目(2021kj45)。

摘　　要：目的建立复方醋酸钠林格注射液中无水葡萄糖含量测定方法,并针对方法建立中发现的葡萄糖转化问题开展研究。方法采用氨基硅烷键合硅胶为填充剂的色谱柱;以乙腈-水-氨水(体积比75∶25∶0.1)为流动相;示差折光检测器检测;流速为1.0 mL/min,柱温和检测池温度均为40℃。结果无水葡萄糖浓度在0.4125~8.249 mg/mL范围内线性关系良好(r=1.0000),定量限为101μg/L,平均回收率为100.5%,RSD为0.5%,采用该测定法发现样品中少量葡萄糖转化为果糖。结论建立的方法简单、准确、灵敏度高,不受葡萄糖转化现象的干扰,适用于复方醋酸钠林格注射液中无水葡萄糖的含量测定。Objective To establish a feasible method for the determination of anhydrous glucose in compound sodium acetate ringers injection.Furthermore,discuss the phenomenon of glucose transformation found in the research process.Methods The amino chemically bonded silica column(250 mm×4.6 mm,5μm)was adopted,the mobile phase was acetonitrile-water-ammonia(75∶25∶0.1).The detector was RID detector.The flow rate was 1.0 mL/min.The column temperature and detector temperature was 40℃.Results The linear range of anhydrous glucose was 0.4125-8.249 mg/mL(r=1.0000),the limit of quantification was 101μg/mL,the average recovery was 100.5%and the RSD was 0.5%.By this developed determination method,it was found that part of glucose in samples was converted into fructose.Conclusion The developed method is simple,accurate with high sensitivity,which could be free from the interference of glucose transformation phenomenon and suitable for the determination of anhydrous glucose in compound sodium acetate ringers injection.

关 键 词：复方醋酸钠林格注射液 无水葡萄糖 葡萄糖转化 

分 类 号：R927.2[医药卫生—药学]