DEVELOPMENT AND VALIDATION OF THE IODOMETRIC METHOD FOR THE QUANTITATIVE DETERMINATION OF AMOXICILLIN
DOI:
https://doi.org/10.32689/2663-0672-2026-1-10Keywords:
oxidation, redox titration method, validation, potassium caroate, amoxicillinAbstract
Background. The development of new methods for quantitative determination of penicillin’s remains relevant. The developed method of quantitative determination of Amoxicillin can be used to develop analytical regulatory documentation for medicinal products, as well as in the practice of state laboratories for quality control of medicinal products and central factory laboratories of pharmaceutical enterprises. Purpose. Development of new improved unified method for the quantitative determination of Amoxicillin (Amox) by redox titration. Materials and Methods. The object of the study was Amox sodium powder in vials for the preparation of an injection solution («Amoxicillin Sodium Salt», 1000 mg). Peroxomonosulfate acid as triple potassium salt 2КНSO5∙КНSO4∙K2SO4 (Oxone®) of “extra pure” qualification was used as oxidant. The redox titration method was used to develop a method for the quantitative determination of amoxicillin in a substance and a medicinal product using potassium caroate as an analytical reagent (KHSO5). Results. The kinetics and stoichiometry of the S-oxidation reaction of Amox with potassium caroate in aqueous solutions were investigated by iodometric titration. A unified methodology was developed and the possibility of qualitative determination of Amox in pure substance and drug using potassium caroate was investigated by redox titration method. At pH 2-4 for 1 mole of penicillin, 1 mole of KHSO5 is consumed, the quantitative interaction is achieved within a time of more than 1 minute (observation time). The results obtained according to the recommended procedure for seven repeated titrations of mixtures of different concentrations. RSD = 0.85%, δ = (+ 0.16)%. Conclusions. Using the redox titration method, a method for the quantitative determination of Amox in the substance was developed and the drug product have been developed using potassium caroate as an analytical reagent (KHSO5). The possibility of analytical determination of Amox by the biologically active part of the molecule is shown, the proposed methods give reproducible and accurate results.
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