DEVELOPMENT AND VALIDATION OF A METHOD FOR DETERMINING THE CONTENT OF RELATIVES IMPURITIES IN THE MEDICINAL PREPARATION AZITROMYCIN
Abstract
The drug is a semi-synthetic antibiotic, the first representative of the subclass of azalides, which is used in the complex treatment of infectious diseases of the respiratory system and ENT organs. such as tonsillitis, pharyngitis, sinusitis, laryngitis; acute chronic bronchitis, pneumonia, otitis media). Currently, there is no literature data on the determination of impurities A, B, C, E, F, G, I, J, L, M, N, O, P of azithromycin. This paper describes the development and validation of methods for determining related impurities in the drug Azithromycin by HPLC.
The aim of the study is to develop and validate a method for determining azithromycin impurities by HPLC for the analytical part of pharmacokinetic studies.
Determination of impurities A, B, C, E, F, G, I, J, L, M, N, O, P in the drug azithromycin.To identify the peaks, chromatography is performed on a high-pressure liquid chromatograph with a UV spectrophotometric detector.
The developed method was validated for the following variational parameters: specificity, checking the suitability of the chromatographic system, specificity, limit of quantitative determination, pretisionality, correctness, linearity and range, robustness.
A method for determining related impurities in the drug Azithromycin by HPLC was developed and validated. The results obtained allow us to apply the developed method when conducting an analysis to determine the content of related impurities in the drug Azithromycin
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