Ceftriaxone (CFTX) sodium is a third-generation, broad-spectrum cephalosporin that is resistant to beta-lactamases. An alternative bioassay for the assessment of the potency of this drug in pharmaceutical formulations has not been previously reported. Thus, this paper reports the development and full validation of a 3 x 3 agar diffusion bioassay using a cylinder-plate method to quantify CFTX sodium in pharmaceutical samples. The strain Staphylococcus aureus ATCC 6538P was used as the test microorganism, and the results of the proposed bioassay displayed high linearity, precision, accuracy, specificity and robustness. All potency results were statistically analyzed using an analysis of variance (ANOVA) and were found to be linear (r=0.99999) in the range of 16-64 µg/mL, accurate (100.5%), and precise [repeatability: relative standard deviation (RSD)=1.4%; intermediate precision: between-day RSD=2.1% and between-analyst RSD=2.5%]. The specificity of the bioassay was determined by evaluating a degraded sample (50 ºC) at 0, 24 and 48 hours as compared against the results from the pharmacopeial liquid chromatography method for CFTX. The results validated the proposed microbiological assay, which allows reliable quantitation of CFTX in pharmaceutical samples. Moreover, it is a useful, simple and low-cost alternative method for monitoring the quality of this medicine.

Cefuroxime (CFU) is a semi-synthetic cephalosporin with a relatively broad-spectrum antimicrobial activity, and belongs to the second generation of cephalosporins. Regarding the quality control of medicines, a validated microbiological assay for determination of cefuroxime sodium in pharmaceutical formulations has not been reported yet With this purpose, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method to quantify CFU sodium in injectable formulations. The assay is based on the inhibitory effect of CFU upon the strain of Staphylococcus aureus ATCC 6538P used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.9998) in the selected range of 8.0-32.0 mu g/ml; precise [repeatability: relative standard deviation (RSD) = 1.56%; intermediate precision: between-day RSD = 1.27%; between analyst RSD = 1.13%] and accurate (101.58%). The bioassay specificity was studied by evaluation of degraded sample at 50 degrees C with analysis at 0, 24 and 48 h in parallel with the pharmacopeial liquid chromatography method for CFU. The results demonstrated the validity of the proposed bioassay, which allows reliable quantitation of CFU sodium in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. (C) 2009 Elsevier B.V. All rights reserved.