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Validation of Erythromycin Microbiological Assay Using an Alternative Experimental Design

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The agar diffusion method, widely used in antibiotic dosage, relates the diameter of the inhibition zone to the dose of the substance assayed. An experimental plan is proposed that may provide better results and an indication of the assay validity. The symmetric or balanced assays (2 2) as well as those with interpolation in standard curve (5 1) are the main designs used in the dosage of antibiotics. This study proposes an alternative experimental design for erythromycin microbiological assay with the evaluation of the validation parameters of the method referring to linearity, precision, and accuracy. The design proposed (3 1) uses 3 doses of standard and 1 dose of sample applied in a unique plate, aggregating the characteristics of the 2 2 and 5 1 assays. The method was validated for erythromycin microbiological assay through agar diffusion, revealing its adequacy to linearity, precision, and accuracy standards. Likewise, the statistical methods used demonstrated their accordance with the method concerning the parameters evaluated. The 3 1 design proved to be adequate for the dosage of erythromycin and thus a good alternative for erythromycin assay.
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Document Type: Research Article

Affiliations: University of So Paulo, Faculty of Pharmaceutical Science, Department of Pharmacy, Ave. Prof. Lineu Prestes, 580 - Block 13, 05508-900, So Paulo, Brazil.

Publication date: July 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 The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better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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