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.
About the Authors
S. I. Kuleshova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
T. I. Pshenichnykh
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. P. Simonova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
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Review
For citations:
Kuleshova S.I., Pshenichnykh T.I., Simonova E.P. Alternative method for determining impurities in antimicrobial medicines. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(4):15-19. (In Russ.)
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