Validation of microbiological assay for determination of cefuroxime in injectable preparations
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Resumo
The validation of a microbiological assay, applying agar diffusion method for determination of the active of cefuroxime in power for injection, is described. Using a strain of Micrococcus luteus ATCC 9341 as the test organism, cefuroxime was measured in concentrations ranging from 30.0 to 120.0 μg/mL. The method validation showed that it is linear (r = 0.9999), precise (relative standard deviation = 0.37%) and accurate (it measured the added quantities). Microbiological assay is satisfactory for quantitation of cefuroxime in powder for injection and the validity of the proposed bioassay, which is a simple and a useful alternative methodology for cefuroxime determination in routine quality control.
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Cefuroxime , Cephalosporins , Microbiological assay , Quality control , Validation , cefuroxime , agar diffusion , bacterial growth , bacterial strain , bacterium culture , calibration , correlation coefficient , drug determination , drug purity , drug structure , limit of detection , limit of quantitation , microbiology , Micrococcus luteus , quality control , validation study
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Inglês
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Latin American Journal of Pharmacy, v. 31, n. 5, p. 746-750, 2012.




