摘要
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.
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.
出处
《药学学报》
CAS
CSCD
北大核心
2005年第6期544-549,共6页
Acta Pharmaceutica Sinica
基金
PACD-FCF-UNESP
关键词
微生物化验
眼科
敏感性
生物鉴定
azithromycin
microbiological assay
cylinder-plate method
ophthalmic solution
pharmaceutical dosage form
quality control
