Analysis of Polymer Impurities in Cephalosporin Antibiotics  

作　　者：Shiqiang OU Yanxi LAI Peng XIE Hao LIU Shicheng LIU Jin QIN Yiping QIN Yizhang WANG Shengjiu GU 

机构地区：[1]Guangxi Kelun Pharmaceutical Co.,Ltd.,Guilin 541800,China [2]College of Pharmacy,Guilin Medical University,Guilin 541199,China

出　　处：《Medicinal Plant》2024年第5期22-26,30,共6页药用植物（英文）

基　　金：Supported by2023 Central Funds for Guiding Local Science and Technology Development(ZY20230102);Guilin City Scientific Research and Technology Development Plan Project(20220104-4).

摘　　要：[Objectives]To establish a HPLC-MS method for the determination of polymer impurities in cefathiamidine and its preparations.[Methods]Kromasil 100-5 C_(18) column(4.6 mm ×250 mm,5μm)was used for analysis;mobile phase ammonium acetate solution(pH 6.30)-acetonitrile,gradient elution;volumetric flow rate 1.0 mL/min;column temperature 40℃;multi-reaction monitoring mode was used for analysis,and positive ion scanning was chosen as the electrospray ion source.[Results]The resolution between impurities and main peaks under this method was greater than 1.5,and 8 known impurities and 2 polymer impurities could be completely separated and distinguish-ed.It was inferred that the molecular ion peak[M+H]^(+):m/z727.1874,m/z 785.1937 was the possible polymer impurity of this product.[Conclusions]A method for the analysis of polymer impurities in cefathiamidine and its preparations was formed,which could achieve the purpose of simultaneous analysis of small molecule impurities and polymer impurities,and could better control the content of single impurities in the polymer,providing a reliable inspection basis for strict control of cefathiamidine quality.

关 键 词：CEFATHIAMIDINE Cephalosporin polymer impurities Impurity analysis High Performance Liquid Chromatography-Mass Spectrometry 

分 类 号：R96[医药卫生—药理学]