Desenvolvimento e validação de ensaio microbiológico para determinação de ciprofloxacino em pomada oftálmica

Abstract

Ciprofloxacin is a second generation fluoroquinolone antimicrobial with a wide spectrum of activity against Gram-positive and Gram-negative bacteria. This paper describes the development and validation of a sensitive, accurate and reproducible microbiological assay, apply agar diffusion method for the determination of ciprofloxacin ophtalmic ointment. The assay is based on the inhibitory effect of ciprofloxacin upon the strain of Staphylococcus epidermidis ATCC12228 used as the test microorganism. The results were treated statistically by analysis of variance (ANOVA) and were found to be linear (r = 0.9903) in the selected range of 4.0 – 32.0 μg mL-1, precise with relative standard deviation (RSD) of repeatability intraday = 0.27, intermediate precision RSD = 0.53, and accurate (101.38%). The results demonstrated the validity of the proposed bioassay, which allows reliable ciprofloxacin quantitation in pharmaceutical samples and therefore can be used for the drug analysis in routine quality control of ciprofloxacin.