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Development of a Microbiological Assay to Determine the Potency of Ceftiofur Sodium Powder

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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 g/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, MI) and of 0.6 for product B (Topcef; Eurofarma Lab. Ltda, So 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.
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Document Type: Research Article

Affiliations: 1: Universidade Federal do Rio Grande do Sul (UFRGS), Faculdade de Farmcia, Programa de Ps-Graduao em Cincias Farmacuticas, Porto Alegre, RS, Brazil; Universidade Federal de Santa Maria (UFSM), Farmcia Industrial, Santa Maria, RS, CEP: 97105-900, Brazil. 2: UFSM, Farmcia Industrial, Santa Maria, RS, CEP: 97105-900, Brazil; UFSM, Programa de Ps-graduao em Cincias Farmacuticas, Santa Maria, RS, CEP: 97105-900, Brazil. 3: UFSM, Programa de Ps-graduao em Cincias Farmacuticas, Santa Maria, RS, CEP: 97105-900, Brazil. 4: UFSM, Programa de Ps-graduao em Engenharia Agrcola, Santa Maria, RS, CEP: 97105-900, Brazil. 5: UFRGS, Faculdade de Farmcia, Programa de Ps-Graduao em Cincias Farmacuticas, Porto Alegre, RS, Brazil.

Publication date: November 1, 2007

More about this publication?
  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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