title: Validation and Application of an LC-MS-MS Method for the Determination of Ceftizoxime in Human Serum and Urine.
abstract: Ceftizoxime sodium is a third-generation cephalosporin available for parenteral administration, which is mainly excreted through urine. A rapid and sensitive ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS-MS) method was developed and validated for the determination of ceftizoxime in human serum and urine. The samples were purified by protein precipitation and separated on an XTerra Phenyl column (4.6 × 50 mm, 5 µm). Electrospray ionization in the positive ion mode and multiple reaction monitoring were used to monitor the ion transitions at m/z 383.9/227.0. The results revealed that the method had excellent selectivity. The linear range covered from 2.50 to 10,000 ng/mL in serum and from 0.500 to 50.0 µg/mL in urine, respectively. Intra-batch and inter-batch precisions (in terms of relative standard deviation) were all <15% and the accuracies (in terms of relative error) were within the range of ± 15%. The lower limit of quantification, stability and extraction recovery were also validated and satisfied the criteria of validation. Finally, the method was successfully applied to a pharmacokinetic study of Chinese elderly healthy subjects after intravenous administration. The Cmax values in serum were 34,721.3 ± 5,697.3 ng/mL. Serum concentrations declined with t1/2 of 2.57 ± 0.22 h.
authors.affiliation: Peking Union Medical College Hospital, N°41 Damucang, Xidan, Xicheng District, Beijing 100032, PR China.
authors.forename: Lu
authors.initials: L
authors.lastname: Wang
authors.affiliation: Peking Union Medical College Hospital, N°41 Damucang, Xidan, Xicheng District, Beijing 100032, PR China.
authors.forename: Xin
authors.initials: X
authors.lastname: Zheng
authors.affiliation: Peking Union Medical College Hospital, N°41 Damucang, Xidan, Xicheng District, Beijing 100032, PR China.
authors.forename: Wen
authors.initials: W
authors.lastname: Zhong
authors.affiliation: Peking Union Medical College Hospital, N°41 Damucang, Xidan, Xicheng District, Beijing 100032, PR China.
authors.forename: Jia
authors.initials: J
authors.lastname: Chen
authors.affiliation: Peking Union Medical College Hospital, N°41 Damucang, Xidan, Xicheng District, Beijing 100032, PR China.
authors.forename: Ji
authors.initials: J
authors.lastname: Jiang
authors.affiliation: Peking Union Medical College Hospital, N°41 Damucang, Xidan, Xicheng District, Beijing 100032, PR China pei.hu.pumc@gmail.com.
authors.forename: Pei
authors.initials: P
authors.lastname: Hu
mesh_terms: D000900:Anti-Bacterial Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine; D015296:Ceftizoxime / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine; D002853:Chromatography, Liquid / Q000379:methods*; D006801:Humans; D012015:Reference Standards; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000900:Anti-Bacterial Agents; D015296:Ceftizoxime