Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)
Alternative method for determining impurities in antimicrobial medicines
Abstract
The article investigates the possibility of using thin-layer chromatography and spectrodensitometer analysis of TLC-chromatograms to determine impurities in ciprofloxacin tablets. HPTLC silica gel 60F254 chromatographic plates and the mobile phase dichloromethane:methanol:ammonia:acetonitrile (30:40:20:10) were used to obtain chromatograms that enabled quantitative determination of ciprofloxacin ethylenediamine analogue in the tablet dosage form. The results of testing were consistent with the data obtained by a validated method. The proposed method makes it possible to determine an identified impurity if the data obtained from tests do not comply with the specification.