title: Verification of cefmetazole and cefpodoxime proxetil contamination to other pharmaceuticals by liquid chromatography-tandem mass spectrometry.
abstract: Cross-contamination is a critical issue for pharmaceutical manufacturing, especially for beta-lactam antibiotics. Thus, an analytical method for the simultaneous determination of beta-lactam antibiotics cefmetazole (CMZ) and cefpodoxime proxetil (CPDXPR) contaminants in non-beta-lactam pharmaceuticals was developed using high-performance liquid chromatography-tandem mass spectrometry. The developed method was found to be sensitive at the detection limit of 0.002 ppm for both compounds. Mean recoveries of CMZ and CPDXPR from olmesartan medoxomil (OLM) tablets were 96.7 to 102.2% and 88.9 to 94.2%, respectively. The developed method was successfully applied for the verification of CMZ and CPDXPR contamination to actually manufactured OLM tablets.
authors.affiliation: Analytical and Quality Evaluation Research Laboratories, Sankyo Co., Ltd., Kanagawa, Japan. fukutu@sankyo.co.jp
authors.forename: Naoto
authors.initials: N
authors.lastname: Fukutsu
authors.forename: Yuich
authors.initials: Y
authors.lastname: Sakamaki
authors.forename: Takao
authors.initials: T
authors.lastname: Kawasaki
authors.forename: Koichi
authors.initials: K
authors.lastname: Saito
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nakazawa
mesh_terms: D015311:Cefmetazole / Q000032:analysis*; D015296:Ceftizoxime / Q000031:analogs & derivatives* / Q000032:analysis; D002853:Chromatography, Liquid / Q000379:methods; D004340:Drug Contamination; D013058:Mass Spectrometry / Q000379:methods; D015394:Molecular Structure; D004364:Pharmaceutical Preparations / Q000032:analysis*; D012680:Sensitivity and Specificity; D013607:Tablets / Q000737:chemistry; D000097627:Cefpodoxime Proxetil
chemical_list: D015311:Cefmetazole; D015296:Ceftizoxime; D004364:Pharmaceutical Preparations; D013607:Tablets; D000097627:Cefpodoxime Proxetil