Development and validation of an agar diffusion assay for determination of ceftazidime in pharmaceutical preparations.
Ceftazidime (CFZ) is a broad spectrum parenteral beta-lactam antibiotic of the cephalosporin family. This paper reports the development and validation of an agar diffusion microbiological assay using the cylinder-plate method for determination of CFZ in powder for injection. The validation carried out yielded good results in terms of linearity, precision, accuracy, selectivity, and robustness. The assay is based on the inhibitory effect of CFZ upon the strain of Pseudomonas aeruginosa ATCC 27853 used as the test microorganism. The results of the assays were treated statistically by analysis of variance and were found to be linear (correlation coefficient = 0.999998) in the selected range of 8.0-32.0 microg/mL; precise [repeatability: relative standard deviation (RSD) = 1.11%; intermediate precision: between-day RSD = 1.37% and between-analyst RSD = 1.41%]; and accurate. The selectivity of the bioassay was evaluated by analysis of degraded samples at 50 degrees C, and the results were compared with a pharmacopeial liquid chromatographic method at the time 0, 24, and 48 h. The results demonstrated the validity of the proposed bioassay, which allows reliable quantitation of CFZ in pharmaceutical samples and can be used as a useful alternative methodology for CFZ analysis in routine quality control.
Schmidt
Cleber A
CA
Centro Universitário Franciscano (UNIFRA), Curso de Farmácia, Rua dos Andradas 1614, CEP 97010-032, Santa Maria, RS, Brazil. cas@unifra.br
Carazzo
Marcelly
M
Laporta
Luciane V
LV
Bittencourt
Celso F
CF
Santos
Marcos R
MR
Friedrich
Milene
M
D000362:Agar; D000900:Anti-Bacterial Agents / Q000032:analysis*; D002138:Calibration; D002442:Ceftazidime / Q000032:analysis*; D004058:Diffusion
D000900:Anti-Bacterial Agents; D000362:Agar; D002442:Ceftazidime