HPLC法测定注射用乙酰谷酰胺中乙酰谷酰胺含量和有关物质  

An HPLC method for the analysis of the content of acetylglutamine and related substances in acetylglutamine for injection

作　　者：周奕彤 王瑞珣 刘然 霍艳双[1] 李清[1] ZHOU Yitong;WANG Ruixun;LIU Ran;HUO Yanshuang;LI Qing(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2021年第11期1165-1174,共10页Journal of Shenyang Pharmaceutical University

基　　金：辽宁省特聘教授课题(2017年);药物一致性评价关键技术与标准研究课题(2017ZX09101001)。

摘　　要：目的建立HPLC法用于注射用乙酰谷酰胺中乙酰谷酰胺的含量和有关物质的分析,为其质量提升提供依据。方法采用反相HPLC法,Agela Venusil MP C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为磷酸盐缓冲液(无水磷酸二氢钾5.44 g,庚烷磺酸钠101.12 mg加水溶解并稀释至1000 mL,磷酸调至pH=2.0),流速为0.6 mL·min^(-1),检测波长为210 nm。结果方法学验证结果表明所建立的方法专属性强、结果准确、稳定性好、可有效测定乙酰谷酰胺的含量和有关物质。结论所建立的方法可为注射用乙酰谷酰胺的质量标准提升提供依据。Objective To establish an HPLC method for the analysis of the content of Acetylglutamine and related substances in Acetylglutamine for injection,and to provide a basis for its quality improvement.Methods Reversed-phase HPLC method,Agela Venusil MP C_(18)column(250 mm×4.6 mm,5μm),and the mobile phase was phosphate buffer(anhydrous potassium dihydrogen phosphate 5.44 g,sodium heptane sulfonate 101.12 mg dissolved in water and diluted to 1000 mL,adjusted to pH=2.0 with phosphoric acid),flow rate was 0.6 mL·min^(-1),and the detection wavelength was 210 nm.Results The methodological verification results showed that the established method used was specific,accurate and stable,and effectively determined the content of Acetylglutamine and related substances.Conclusion The established method can provide a basis for improving the quality standard of Acetylglutamine for injection.

关 键 词：乙酰谷酰胺 注射剂 离子对色谱法 有关物质 

分 类 号：R917[医药卫生—药物分析学]