乙酰谷酰胺注射液中有关物质的研究  

Study on the relevant substance in aceglutamide injection

作　　者：王燕 钱伟钢 厉昌卫 徐菁华 孙东艳 周华娜 王雪敏 

机构地区：[1]上海朝晖药业有限公司,上海201908 [2]南京泽恒医药技术开发有限公司,南京210046

出　　处：《上海医药》2016年第9期71-75,共5页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:建立HPLC法测定乙酰谷酰胺注射液中的有关物质。方法:HPLC检测采用Sepax HP-C_(18)柱、以0.1%的高氯酸水溶液-甲醇(99∶1)为流动相、检测波长为210 nm、柱温25℃。结果:6个有关物质能较好地分离,专属性、线性、定量限、检测限、校正因子、系统精密度、溶液稳定性、重复性均符合2010年版中国药典要求,结论:该方法可将乙酰谷酰胺注射液中的乙酰谷酰胺与6个有关物质完全分离。Objective： To establish an HPLC method for determination of relevant substances in aceglutamide injection. Methods： HPLC was performed on a Sepax HP-C18 column with a mobile phase of 0.1% perchloric acid and methanol （99：1） at detection wavelength of 210 nm and column temperature of 25 ℃. Results： Six relevant substances were well separated. The specificity, linearity, limit of quantitation and detection, correction factor, system precision, solution stability and repeatability were conformed to the requirements of 2010 version of Chinese Pharmacopoeia. Conclusion： Aceglutamide can be completely separated with 6 relevant substances in aceglutamide injection by this method.

关 键 词：乙酰谷酰胺注射液 HPLC 有关物质 

分 类 号：R927.1[医药卫生—药学]