Validation of microbiological assay for determination of cefuroxime in injectable preparations

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.

Keywords

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