Microbiological assay for cefoxitin sodium in dosage form

A microbiological assay applying the cylinder-plate method is described for determination of the activity of cefoxitin sodium in injectables. Using a strain of Staphylococcus epidermidis ATCC 12226 as the test organism, cefoxitin sodium was measured in concentrations ranging from 50.0 to 200.0 mu g/mL. The validation showed that the method was linear (r = 0.9998), precise (RSD 0.81%), and accurate. It was concluded that the microbiological assay is satisfactory for quantitation of cefoxitin sodium in injectables.

Microbiological assay for ceftazidime injection

A simple, sensitive, and specific biodiffusion assay for the! antibacterial ceftazidime was developed using a strain of Staphylococcus epidermidis (ATCC 12228) as the test organism. Ceftazidime was measured in powder for injection at concentrations ranging from 100 to 400 mu g/mL. The calibration graph for ceftazidime was linear (r(2) = 1), and the method validation showed that it was precise (relative standard deviation = 0.415) and accurate. The results obtained by biodiffusion assay were statistically calculated by linear parallel model and by means of regression analysis and were verified using analysis of variance. It was concluded that the microbiological assay is satisfactory for in vitro quantification of the antibacterial activity of ceftazidime in pharmaceuticals.

Microbiological assay for gatifloxacin in pharmaceutical formulations

A simple, sensitive and specific agar diffusion bioassay for the antibacterial gatifloxacin was developed using a strain of Bacillus subtilis ATCC 9372 as the test organism. Gatifloxacin could be measured in tablets and raw material at concentration ranging 4-16 mu g ml(-1). The calibration graph for gatifloxacin was linear from 4.0 to 16.0 mu g ml(-1). A prospective validation of the method demonstrated that the method was linear (r(2) = 0.9993), precise (R.S.D. = 1.14%) and accurate. The results confirmed its precision and did not differ significantly from others methods described in the literature. The validated method yielded good results in terms of the range, linearity, precision, accuracy, specificity and recovery. We concluded that the microbiological assay is satisfactory for in vitro quantification of the antibacterial activity of gatifloxacin. (c) 2005 Elsevier B.V. All rights reserved.

Microbiological assay for lomefloxacin in coated tablets

The validation of a microbiological assay, applying cylinder plate method for determination of the activity of lomefloxacin in coated tablets is described. Using a strain of Bacillus subtilis ATCC 9372 as the test organism, lomefloxacin was measured in concentrations ranging from 2.0 to 8.0 mu g/mL. The method validation showed that it is linear (r = 0.9999), precise (relative standard deviation 1.15%), and accurate (it measured the added quantities). The excipients did not interfere in the determination. It was concluded that the microbiological assay is satisfactory for quantitation of lomefloxacin in tablets.

Microbiological assay for the determination of azithromycin in ophthalmic solutions

The validation of a simple, sensitive and specific agar diffusion bioassay, applying cylinder-plate method, for the determination of the antibiotic azithromycin in ophthalmic solutions is described. Using a strain of Bacillus subtilis ATCC 9372 as the test organism, azithromycin at concentrations ranging from 50.0 to 200.0 μg·mL-1 could be measured in 1.666 7 mg·mL-1 ophthalmic solutions. A prospective validation of the method showed that the method was linear (r = 0.999 9) and precise (RSD = 0.70) and accurate (it measured the added quantities). The results obtained by bioassay method could be statistically calculated by linear parallel model and by means of regression analysis and verified using analysis of variance (ANOVA). We conclude that the microbiological assay is satisfactory for quantification of azithromycin in ophthalmic solutions.

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.

Development and validation of a microbiological assay for determination of chlorhexidine digluconate in aqueous solution

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Development and validation of a microbiological assay by turbidimetry to determine the potency of cefazolin sodium in the lyophilized powder form

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Microbiological Assay for the Determination of Colistin Sulphate

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

A novel and rapid microbiological assay for ciprofloxacin hydrochloride

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Development and validation of a microbiological agar assay for determination of orbifloxacin in pharmaceutical preparations

Orbifloxacin is a fluoroquinolone with broad-spectrum antimicrobial activity, and belongs to the third generation of quinolones. Regarding the quality control of medicines, a validated microbiological assay for determination of orbifloxacin in pharmaceutical formulations has not as yet been reported. For this purpose, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method to quantify orbifloxacin in tablet formulations. The assay is based on the inhibitory effect of orbifloxacin upon the strain of Staphylococcus aureus ATCC 25923 used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.9992) in the selected range of 16.0-64.0 μg/mL, precise with relative standard deviation (RSD) of repeatability intraday = 2.88%, intermediate precision RSD = 3.33%, and accurate (100.31%). The results demonstrated the validity of the proposed bioassay, which allows reliable orbifloxacin quantitation in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. © 2011 by the authors; licensee MDPI, Basel, Switzerland.

Development and validation of a successful microbiological agar assay for determination of ceftriaxone sodium in powder for injectable solution

Ceftriaxone sodium is a cephalosporin with broad-spectrum antimicrobial activity and belongs to the third generation of cephalosporins. Regarding the quality control of medicines, a validated microbiological assay for the determination of ceftriaxone sodium in powder for injectable solution has not been reported yet. This paper reports the development and validation of a simple, accurate and reproducible agar diffusion method to quantify ceftriaxone sodium in powder for injectable solution. The assay is based on the inhibitory effect of ceftriaxone sodium on the strain of Bacillus subtilis ATCC 9371 IAL 1027 used as test microorganism. The results were treated statistically by analysis of variance and were found to be linear (r = 0.999) in the selected range of 15.0-60.0 μg/mL, precise with a relative standard deviation (RSD) of repeatability intraday = 1.40%, accurate (100.46%) and robust with a RSD lower than 1.28%. The results demonstrated the validity of the proposed bioassay, which allows reliable ceftriaxone sodium quantitation in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. © 2012 by the authors; licensee MDPI, Basel, Switzerland.

Development and validation of a stability-indicative agar diffusion assay to determine the potency of linezolid in tablets in the presence of photodegradation products

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Clinical and microbiological changes after minimally invasive therapeutic approaches in intrabony defects: a 12-month follow-up

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Development and validation of a rapid turbidimetric assay to determine the potency of cefuroxime sodium in powder for dissolution for injection

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)