摘要
目的建立了注射用美罗培南中美罗培南聚合物的测定方法。方法采用TSK GEL G2000SW/600凝胶柱,以磷酸盐缓冲液(pH 7.0)[0.01 mol/L磷酸氢二钠溶液-0.01 mol/L磷酸二氢钠溶液(61:39)]为流动相,流速为0.5 ml/min,检测波长为254 nm,外标法计算聚合物的含量。结果美罗培南聚合物与美罗培南能较好地分离;美罗培南浓度在0.5040～4.0359 mg/ml范围内,与美罗培南峰面积或聚合物峰面积和的线性关系良好,重复性RSD为2.41%(n=6)。结论所采用的方法科学、简便、结果可靠,可用于注射用美罗培南聚合物的检测。
Objective To establish a method for the determination of high molecular weight impurities in Meropenem for Injection.Methods TSK GEL G2000SW/600 was adopted,using phosphate buffer[pH 7.0,0.01 mol/L disodium hydrogen phosphate and sodium dihydrogen phosphate solution(61:39)],and the flow rate was 0.5 ml/min.The detection wavelength was set at 254 nm.Calculation of the content of high molecular weight impurities was performed by external standard method.Results High molecular weight impurities in meropenem was separated completely from meropenem.The linear range of meropenem was 0.5040-4.0359 mg/ml.The repetitiveness was fine(RSD=2.41%,n=6).Conclusion The method is scientific,simple,rapid and reliable.It is applicable for the quality control of high molecular weight impurities in meropenem.
作者
于会贤
黄世青
石凯
YU Hui-xian;HUANG Shi-qing;SHI Kai(Shenyang Pharmaceutical University,Shenyang 110015,China;Shenzhen South China Pharmaceutical (NCPC) Co.,Ltd.,Shenzhen 518106,China)
出处
《食品与药品》
CAS
2019年第2期130-133,共4页
Food and Drug
关键词
注射用美罗培南
高效凝胶色谱法
聚合物
Meropenem for injection
high performance gel permeation chromatography
high molecular weight impurity
