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Turbidimetric Method for Standardization and Quality Control of Aminoglycoside Antibiotics and Aminoglycoside-Based Products

Abstract

The article covers microbiological methods that help assess the biological activity of antibiotics, which is fundamental for determination of clinical efficacy of antimicrobial drugs. The authors chose gentamicin, an aminoglycoside antibiotic, to illustrate the development and validation of the turbidimetric assay, which is based on antibiotic's inhibitory effect on the growth of Staphylococcus aureus ATCC 6538Р test strain in liquid medium. The obtained data were assessed with ANOVA and were recognized as linear (r=0.9921) in the concentration range of 0.64-1.56 mg/ml. The results of gentamicin assay validation studies demonstrate great potential and applicability of the turbidimetric method for standardization and ensuing quality control of aminoglycoside antibiotics.

About the Authors

Yu. V. Olefir
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation


E. N. Semenova
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation


S. I. Kuleshova
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation


E. I. Sakanyan
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation


S. A. Protsak
Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Russian Federation


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Review

For citations:


Olefir Yu.V., Semenova E.N., Kuleshova S.I., Sakanyan E.I., Protsak S.A. Turbidimetric Method for Standardization and Quality Control of Aminoglycoside Antibiotics and Aminoglycoside-Based Products. Antibiot Khimioter = Antibiotics and Chemotherapy. 2018;63(7-8):62-66. (In Russ.)

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ISSN 0235-2990 (Print)