TSK凝胶色谱系统测定多尼培南原料药中高分子聚合物  

Determination of High Molecular Polymers of Doripenem by TSK Gel Chromatography System

作　　者：李用珍 刘兆讯 王军军 张英 王龙江 LI Yong-zhen;LIU Zhao-xun;WANG Jun-jun;ZHANG Ying;WANG Long-jiang(Shandong Dyne Marine Biopharmaceutical Co., Ltd., Rongcheng 264300, China;Department of Food Engineering, Weihai Ocean Vocational College, Rongcheng 264300, China)

机构地区：[1]山东达因海洋生物制药股份有限公司,山东荣成264300 [2]威海海洋职业学院食品工程系,山东荣成264300

出　　处：《食品与药品》2019年第5期371-375,共5页Food and Drug

摘　　要：目的建立多尼培南原料药中高分子聚合物的检测方法。方法采用TSK-GELG2000SW色谱柱,以pH7.0磷酸盐缓冲液:乙腈=90:10(v/v)为流动相,流速:0.7ml/min,检测波长:298nm,柱温:30℃。结果主成分与高分子聚合物能完全分离。多尼培南在0.1~8μg/ml范围内的峰面积与浓度的线性关系良好(n=5),线性相关系数r=0.9999,检测限为0.04μg/ml。多尼培南主峰前杂质峰面积之和与样品质量的比值(A/M)RSD为1.59%(n=12),中间精密度良好;各色谱条件发生微小变化,与原色谱条件相比RD均在±2%以内。结论该方法简便、灵敏、准确、专属性强,可用于多尼培南高分子聚合物的检查。Objective To establish a method for the determination of high molecular weight polymers in doripenem. Methods The determination was performed on a TSK-GEL G2000SW column with mobile phase consisted of pH 7.0 phosphate buffer solution-acetonitrile (90:10, v/v) at the flow rate of 0.7 ml/min. The detection wavelength was 298 nm, the temperature for chromatographic column was 30 ℃. Results The main component was completely separated from the polymers. The linear relationship between the peak area and concentration was good in the range of 0.1-8 μg/ ml (n=5, r=0.9999) with the detection limit of 0.04 μg/ml. The RSD of the ratio between the total area of the impurities in front of the the main peak of dorepene and the weight (A/M) was 1.59 (n=12), and the precision was good. When the chromatographic conditions changed slightly, the RD was within ±2 %. Conclusion This method is convenient, sensitive, accurate and specific. It can be used for the determination of high molecular weight polymers in doripenem.

关 键 词：多尼培南 聚合物 TSK凝胶色谱 

分 类 号：R917[医药卫生—药物分析学]