Microbiological bioassay of erythromycin thiocyanate: optimisation and validation

The validation of an analytical method for the quantitative determination of erythromycin thiocyanate formulated in an antibiotic preparation for veterinary use was carried out. This method is based on the microbiological method described in the European Pharmacopoeia to analyze erythromycin thiocya...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 1999-11, Vol.21 (2), p.347-353
Main Authors: Bernabéu, J.A., Camacho, M.A., Gil-Alegre, M.E., Ruz, V., Torres-Suárez, A.I.
Format: Article
Language:English
Subjects:
Administration, Oral
Analysis
Animal Feed - analysis
Antibacterial agents
Antibiotics. Antiinfectious agents. Antiparasitic agents
Bacillus subtilis
Biological and medical sciences
Biological Assay - methods
Biological Assay - veterinary
Calibration
Erythromycin - administration & dosage
Erythromycin - analogs & derivatives
Erythromycin - analysis
Erythromycin thiocyanate
General pharmacology
Inhibition zones correction
Medical sciences
Microbiological assay
Pharmacology. Drug treatments
Powders - analysis
Regression Analysis
Reproducibility of Results
Validation
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Summary:The validation of an analytical method for the quantitative determination of erythromycin thiocyanate formulated in an antibiotic preparation for veterinary use was carried out. This method is based on the microbiological method described in the European Pharmacopoeia to analyze erythromycin thiocyanate as a raw material. This erythromycin thiocyanate preparation is presented as a powder for oral administration after mixing with feed. For that reason, it was planned to validate the method for the quantitative determination of erythromycin thiocyanate incorporated both in the medicated premix and the mixture with feed. The microbiological method followed a linear model and was not proportional. The number of replicates needed to obtain a valid result was less than four in all cases. The small difference in concentration, expressed in natural logarithm detected by the method, was 0.1.
ISSN:0731-7085
1873-264X
DOI:10.1016/S0731-7085(99)00143-0