摘要
Abstract
Objective To establish determination of polymer content in cefdinir by Polystyrene-High Performance Liquid Chromatography.Methods A TSKgel G2000SWxl (7.8í300mm 5um) column was adopt with the polystyrene gel column fil er mobile phase was 0.1mol/L pH=7.0 buf er solution-methanol (95:5), the flow rate was 0.5ml/min The detection wavelength was 285nm, to identify the impurities by HPLC-ESI-MS.Results The calibration curves for cefdinir in the range of 0.0002mg/ml ~ 1.5mg/ml was linear (r = 1.0000) the detection limit was 0.2ug/ml, the peaks before cefuroxime axetil in the chromatogram were high molecular mass impurities, the resolution between cefuroxime axetil and high molecular mass impurities was good. The high molecular mass impurities is instable in so-lution ,and the test solution should be prepared immediately before use. Conclusion The established method is fast for analysis and good for precision ,it's suitable for determinate the polymer in cefdinir and it's preparation.关键词
高效液相色谱/聚苯乙烯凝胶/头孢地尼/聚合物/β-内酰胺类抗生素/过敏原Key words
HPLC/Polystyrene gel/Cefdinir/polymer/β-lactam antibiotics/Al ergens