Identification of the related substances in ceftazidime for injection by LC-MS techniques
WANG Shuang-shuang
SONG Fan
HANG Tai-jun
SONG Min
Abstract：Objective:To identify the related substances in ceftazidime for injection by LC-MS techniques for its stability study and quality control.Methods:A Thermo Syncronis C18 (250 mm × 4.6 mm,5 μm) column was used for separation of the related substances with a mixture of acetonitrile and ammonium acetate buffer as the mobile phase in gradient elution.Electrospray positive ionization high resolution TOF/MS was used for determining the accurate mass and elemental composition of parent ions of the related substances.Triple quadrupole tandem mass was employed for determining the product mass spectra.The structures of the related substances were then figured out through the elucidation of the fragment ions.Results:Ceftazidime and the related substances were separated under the established HPLC conditions.Nine major related substances in ceftazidime were detected and speculated by the hyphenated techniques.The four major impurities were recorded in British Pharmacopoeia,while another five were not reported before.Conclusion:The established LC-MS method is effective for separation and identification of the related substances in ceftazidime,and the results are useful for the stability study and quality control of ceftazidime.
Keywords：ceftazidimerelated substancesdegradation productsstructure identificationLC-MS
Publication Date：2018-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 102-109 )