Separation and characterization of allergenic polymerized impurities from cephalosporin for injection by trap free two-dimensional high performance size exclusion chromatography × reversed phase liquid chromatography coupled with ion trap time-of-flight mass spectrometry

Wang, 2012, Determination of the polymer in cefalor capsules in SEC, Strait Pharm. J., 24, 41 Gao, 2013, The research progress of high polymers in antibiotics combinations containing β-lactamase inhibitors, World Notes Antibiot., 34, 52 Wang, 2015, Determination of the polymers in cefuroxime axetil by HPLC, Pharm. Clin. Res., 20, 467 Zhang, 2008, Determination for dimer and related substances of ampicillin sodium, and ampicillin sodium injection by HPLC, Tianjin Pharm., 20, 21 Chen, 2006, Determination of the polymers in cefodizime sodium for injection, Drug Stand. China, 7, 60 Zhou, 2002, Process development on the determination of high molecular weight impurities in cephalosporin, Chin. J. Antibiot., 27, 181 F.Q, 2016, Polymer impurities in cefotiam hydrochloride by online 2D-GFC-RPLC-TOF MS, Chin. Pharm. J., 51, 742 Cai, 2005, Chromatographic determination of polymerized impurities in meropenem, J. Pharm. Biomed. Anal., 37, 585, 10.1016/j.jpba.2004.11.023 Hou, 2012, Review on the research and detection method of high molecular weight impurities in β-lactam antibiotics, Pharm. Clin. Res., 20, 240 National Pharmacopoeia Committee, 2015 Hu, 2008, Developments on analysis of polymers of β-lactam antibiotics, Chin. J. New Drug, 24, 2098 Wu, 2013, Determination of polymer of cefoperazone sodium for injection by HPSCE, Pharm. J. Chin. PLA, 20, 157 Xu, 2017, Separation and characterization of unknown impurities and isomers in flomoxef sodium by LC-IT-TOF MS and study of their negative-ion fragmentation regularities, J. Pharm. Biomed. Anal., 140, 81, 10.1016/j.jpba.2017.03.032 Huang, 2008, Anal. Chim. Acta, 615, 124, 10.1016/j.aca.2008.03.056 Wang, 2017, Separation and characterization of unknown impurities in cefonicid sodium by trap-free two-dimensional liquid chromatography combined with ion trap time-of-flight mass spectrometry, Rapid Commun. Mass Spectrom., 31, 1541, 10.1002/rcm.7934 Luo, 2017, 2D-LC as an on-line desalting tool allowing peptide identification directly from MS unfriendly HPLC methods, J. Pharm. Biomed. Anal., 137, 139, 10.1016/j.jpba.2016.11.012 Dai, 2017, Compatibility study of a parenteral microdose polyethylene glycol formulation in medical devices and identification of degradationimpurity by 2D-LC/MS, J. Pharm. Biomed. Anal., 137, 182, 10.1016/j.jpba.2017.01.036 Wang, 2017, Application of a trap-free two-dimensional liquid chromatography combined with ion trap/time-of-flight mass spectrometry for separation and characterization of impurities and isomers in cefpiramide, Anal. Chim. Acta, 992, 42, 10.1016/j.aca.2017.08.028 Xu, 2017, Separation and characterization of allergic polymerized impurities in cephalosporins by 2D-HPSEC × LC-IT-TOF MS, J. Pharm. Biomed. Anal., 145, 742, 10.1016/j.jpba.2017.07.063 Cai, 2003, Chromatographic determination of high-molecular weight impurities in amoxicillin, J. Pharm. Biomed. Anal., 31, 589, 10.1016/S0731-7085(02)00711-2 Jiang, 2007, Research progess in the high molecular weight impurities of cephalosporins, World Notes Antibiot., 28, 264 Wang, 2011, Determination of high molecular weight impurities in cefadroxil capsules in HPSEC, Chin. Pharm. J., 46, 1027