Aim: To establish a sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the determination of isomeric impurity in raw drug material of cefepime dihydrochloride.
Methods: The HPLC separation experiments were performed on a reversed phase C18 column, with acetonitrile-10 mmol x L(-1) ammonium acetate (5:95) as mobile phase (a flow rate of 0.8 mL x min(-1)). The analytes were determined by electrospray ionization tandem mass spectrometry in positive mode. The chromatogram and mass spectra of cefepime dihydrocloride and its isomeric impurity were obtained by LC-MS/MS.
Results: The method can be used for the separation and identification of cefepime dihychrocloride and its isomeric impurity, of which the retention times were 15.28 min and 9.18 min, respectively. Based on the MS/MS spectra of their molecular ions, the different fragmentation pathways of cefepime dihydrocloride and its isomeric impurity were compared and proposed.
Conclusion: The method was rapid, sensitive and specific. It can be used for the identification of the isomeric purity in raw drug material of cefepime dihydrochloride.
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