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Microbiological assay for cefoxitin sodium in dosage form
Hérida Regina Nunes Salgado1, Greici Cristiani Gomes Tozo
1Faculdade de Ciências Farmacêuticas, Programa de Pós-graduação em Ciências Farmacêuticas, UNESP, Rod. Araraquara-Jaú, km 1, CEP 14801-902, Araraquara, SP, Brazil. salgadoh@fcfar.unesp.br
Journal of AOAC International
|May 4, 2007
Summary
A validated microbiological assay using Staphylococcus epidermidis accurately quantifies cefoxitin sodium in injectables. This cylinder-plate method provides a reliable approach for determining cefoxitin sodium activity.
Area of Science:
- Microbiology
- Analytical Chemistry
- Pharmaceutical Science
Background:
- Cefoxitin sodium is a vital antibiotic used in injectable formulations.
- Accurate quantification of active pharmaceutical ingredients is crucial for drug efficacy and safety.
Purpose of the Study:
- To describe and validate a microbiological assay for determining cefoxitin sodium activity in injectable products.
- To establish a reliable method for cefoxitin sodium quantitation.
Main Methods:
- Application of the cylinder-plate method, a standard microbiological assay technique.
- Utilizing Staphylococcus epidermidis ATCC 12226 as the indicator organism.
- Testing cefoxitin sodium concentrations within the range of 50.0 to 200.0 microg/mL.
Main Results:
- The microbiological assay demonstrated excellent linearity (r = 0.9998).
- The method exhibited high precision with a relative standard deviation (RSD) of 0.81%.
- The assay proved to be accurate for cefoxitin sodium determination.
Conclusions:
- The described microbiological assay is a satisfactory and validated method for the quantitation of cefoxitin sodium in injectable formulations.
- This method ensures reliable quality control for cefoxitin sodium injectables.
