Separation and characterization of a new isomeric impurity in cefalotin sodium by HPLC and MEKC

• 作 者: MeichengYang;HaoLiu;FengQin;YaQiu;XinWang;ZhenFeng;
• 机 构: Division of Antibiotics,Shanghai Institute for Food and Drug Control,Shanghai,P.R.China
• 出 处: 2014年中国药学大会暨第十四届中国药师周
• 发表日期: 2014年期

　　A micellar electrokinetic chromatography (MEKC) method was developed for the determination of impurities in cefalotin sodium.The optimized separation is performed with the background electrolyte composed of 25 mM sodium tetraborate buffer (pH 9.2) containing 0.2 M sodium dodecylsulfate and an applied voltage of 30 kV in a bare fused-silica capillary (50 μm i.d×64.5 cm,56 cm detection length).The method was validated in terms of linearity,accuracy,precision,robustness,LOD and LOQ.Analyzing the commercial cefalotin sodium and cefalotin sodium CRS with the novel MEKC method,a new impurity was detected in the range of 0.99-1.36% level along with the potential known impurities,which was co-eluted with the main product in the pharmacopoeia HPLC systems.The new impurity was confirmed to be 3-positional isomer of cefalotin by synthesis,1H NMR spectrometry and MEKC techniques.