Development of a microbiological assay to determine the potency of ceftiofur sodium powder

被引：0
|
作者：
Souza, Marinês J.E. [1 ,2 ]
Rolim, Clarice M.B. [2 ,3 ]
Melo, Janine [3 ]
Filho, Paulo S. Souza [4 ]
Bergold, Ana M. [1 ]
机构：
[1] Universidade Federal do Rio Grande do sul (UFRGS), Faculdade de Farmácia, Programa de Pós-Graduação em Ciências Farmacêuticas, Porto Alegre, RS, Brazil
[2] Universidade Federal de Santa Maria (UFSM), Farmácia Industrial, Santa Maria, RS, CEP: 97105-900, Brazil
[3] UFSM, Programa de Pós-graduação em Ciências Farmacêuticas, Santa Maria, RS, CEP: 97105-900, Brazil
[4] UFSM, Programa de Pós-graduação em Engenharia Agrícola, Santa Maria, RS, CEP: 97105-900, Brazil
来源：
Journal of AOAC International | 1600年 / 90卷 / 06期
关键词：
Ceftiofur sodium is a third-generation broad-spectrum cephalosporin antibiotic; formulated as an intramuscular injection; that is approved for use in pigs; cattle; poultry; and dogs. The present work reports a method to quantify ceftiofur in powder for injection by comparing the cylinder plate assay and the liquid chromatographic (LC) method. The assay is based on the inhibitory effect of ceftiofur upon the strain of Micrococcus luteus ATCC 10240 used as the test microorganism. Ceftiofur sodium at concentrations ranging from 2.0 to 8.0 μg/mL can be measured in powder for injection. A prospective validation showed that the method is linear (r2 = 0.9998); with precise relative standard deviation (RSD) of 0.8% for product A (Excenel® Pharmacia and Upjohn Co; Kalamazoo; Ml) and of 0.6% for product B (Topcef® Eurofarma Lab. Ltda; São Paulo; Brazil); with intermediate precision; between-day RSD = 1.0 and 1.1%; between-analyst RSD = 0.8 and 0.8% for products A and B; respectively and accurately. The comparison between bioassay and LC by analysis of variance and Student's t-test showed no significant difference among methodologies. The results demonstrated the validity of the proposed bioassay that is simple and a useful alternative methodology for analysis of ceftiofur in routine quality control;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Journal article (JA)
引用
收藏
页码：1724 / 1728
相关论文
共 50 条
  • [1] Development of a microbiological assay to determine the potency of ceftiofur sodium powder
    Souza, Marines J. E.
    Rolim, Clarice M. B.
    Melo, Janine
    Souza Filho, Paulo S.
    Bergold, Ana M.
    JOURNAL OF AOAC INTERNATIONAL, 2007, 90 (06) : 1724 - 1728
  • [2] Development and validation of a microbiological assay by turbidimetry to determine the potency of cefazolin sodium in the lyophilized powder form
    Pedroso, Tahisa Marcela
    Nunes Salgado, Herida Regina
    ANALYTICAL METHODS, 2014, 6 (05) : 1391 - 1396
  • [3] Development and Validation of a Rapid Turbidimetric Assay to Determine the Potency of Cefuroxime Sodium in Powder for Injection
    Vieira, Daniela C. M.
    Fiuza, Thalita F. M.
    Salgado, Herida R. N.
    PATHOGENS, 2014, 3 (03) : 656 - 666
  • [4] Development and validation of a rapid turbidimetric assay to determine the potency of ampicillin sodium in powder for injectable solution
    Totoli, Eliane Gandolpho
    Nunes Salgado, Herida Regina
    ANALYTICAL METHODS, 2013, 5 (21) : 5923 - 5928
  • [5] A fully validated microbiological assay to evaluate the potency of ceftriaxone sodium
    Manfio, Maria Luisa
    Agarrayua, Danielle Araujo
    Machado, Jaison Carlosso
    Schmidt, Cleber Alberto
    BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2013, 49 (04) : 753 - 762
  • [6] Rapid Turbidimetric Assay to Determine the Potency of Daptomycin in Lyophilized Powder
    Totoli, Eliane Gandolpho
    Nunes Salgado, Herida Regina
    PHARMACEUTICS, 2015, 7 (03) : 106 - 121
  • [7] Development of an Ultraviolet Spectrophotometric Method for the Determination of Ceftiofur Sodium Powder
    Souza, Marines J. e
    Canedo, Natalia A. P.
    Souza Filho, Paulo S.
    Bergold, Ana M.
    JOURNAL OF AOAC INTERNATIONAL, 2009, 92 (06) : 1673 - 1680
  • [8] Development and validation of a rapid turbidimetric assay to determine the potency of norfloxacin in tablets
    Chierentin, Lucas
    Nunes Salgado, Herida Regina
    BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2015, 51 (03) : 629 - 635
  • [9] Using image analysis to determine gentamicin potency by agar diffusion microbiological assay and its measurement uncertainty
    Saviano, Alessandro Morais
    Lourenco, Felipe Rebello
    MEASUREMENT, 2019, 146 : 315 - 321
  • [10] Miniaturized Microbiological Method to Determine the Potency of Rifaximin in Tablets
    Motta Correa, Clara Bersi
    Kogawa, Ana Carolina
    Chorilli, Marlus
    Nunes Salgado, Herida Regina
    JOURNAL OF AOAC INTERNATIONAL, 2021, 104 (04) : 1049 - 1054
12345