Verification of cefmetazole and cefpodoxime proxetil contamination to other pharmaceuticals by liquid chromatography-tandem mass spectrometry.
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.
Fukutsu
Naoto
N
Analytical and Quality Evaluation Research Laboratories, Sankyo Co., Ltd., Kanagawa, Japan. fukutu@sankyo.co.jp
Sakamaki
Yuich
Y
Kawasaki
Takao
T
Saito
Koichi
K
Nakazawa
Hiroyuki
H
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
D015311:Cefmetazole; D015296:Ceftizoxime; D004364:Pharmaceutical Preparations; D013607:Tablets; D000097627:Cefpodoxime Proxetil