Microbiological assay for the determination of telithromycin in tablets.
This study describes the development and validation of a microbiological assay, applying the cylinder-plate method, for the determination of the antibiotic telithromycin. The microbiological method consisted of a cylinder-plate agar diffusion assay using Micrococcus luteus ATCC 9341 as the test microorganism. The response graphs for standard and sample solutions were linear (r = 0.9987), and no parallelism deviations were detected in the tested concentrations (0.25, 0.5, and 1.0 microg/mL). The interday precision was 2.67%. Recovery values were between 96.75 and 100.91%. A preliminary stability study of telithromycin showed that the microbiological assay is specific for the determination of telithromycin in the presence of its degradation products. The proposed method allows the quantitation of telithromycin in pharmaceutical dosage form and can be used for drug analysis in routine quality control.
Vaucher
Lauren C
LC
Universidade Federal do Rio Grande do Sul, Faculdade de Farmácia, Programa de Pós-Graduação em Ciências Farmacêuticas, Av. Ipiranga, Porto Alegre-RS, Brazil. lauren@farmacia.ufrgs.br
Breier
Ana R
AR
Schapoval
Elfrides E S
EE
D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000032:analysis / Q000494:pharmacology / Q000592:standards; D001431:Bacteriological Techniques / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D001681:Biological Assay / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D048628:Ketolides / Q000008:administration & dosage / Q000032:analysis* / Q000494:pharmacology / Q000592:standards; D016982:Micrococcus luteus / Q000187:drug effects; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013607:Tablets
D000900:Anti-Bacterial Agents; D048628:Ketolides; D013607:Tablets; C106791:telithromycin