TURBIDIMETRIC METHOD IN DETERMINING THE BIOLOGICAL ACTIVITY OF AMINOGLYCOSIDE ANTIBIOTICS

DOI: https://doi.org/10.29296/25419218-2019-05-08
Issue: 
5
Year: 
2019

E.N. Semenova, S.I. Kuleshova, A.I. Luttseva, E.I. Sakanyan 2Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation, 8, Petrovsky Boulevard, Build. 2, Moscow 127051, Russian Federation

Introduction. Antibiotics are the most widely used group of drugs. Therefore, the standardization and subsequent quality control of drugs in the antibiotic group are of particular relevance. Objective: to develop a turbidimetric method to quantify neomycin sulfate in the medicines used in the Russian Federation. Material and methods. Solutions of neomycin sulfate concentration in the range of 1.5 to 3.66 IU/ml were assessed using the experimental nutrient medium inoculated with Staphylococcus aureus ATCC 6538P in an amount of 2% after 4.5-hour incubation. Results. The turbidimetric procedure for determining the biological activity of the aminoglycoside antibiotic neomycin sulfate was validated according to the following parameters: linearity, precision, accuracy, stability, and specificity. Conclusion. The results of validation tests of the procedure for the quantification of neomycin sulfate provide evidence that the turbidimetric method can determine the biological activity of aminoglycoside antibiotics in research and analytical laboratories and at enterprises. The developed procedure can significantly reduce the time of analysis.

Keywords: 
aminoglycoside antibiotic
quantitative determination
turbidimetric method
standardization
quality assessment

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