Y. Wei-feng
2013
Citations
0
Influential Citations
3
Citations
Journal
Chinese Journal of Pharmaceutical Analysis
Abstract
Objective:To establish an HPLC-Q-TOF-MS method for the identification of major impurities in cefradine.Methods:The HPLC was performed on a Kromasil 100-5C18 column(250 mm×4.6 mm,5 μm) with methanol-10 mmol·L-1 a mmonium acetate(30∶ 70) as mobile phase.Data was collected under positive ion modes with ESI as ion resource.Results:The method identified an impurity with the content of 1.32% as dihydrocefradine based on analysis the feature fragmentation from Q-TOF.It was speculated that the impurity was introduced by intermediate dihydrophenylglycine impurities involved in the synthesis process.Conclusion:The method identified an unknown impurity in cefradine,and thus provide reference to its quality control and process optimization.