QUANTITATIVE DETERMINATION OF AMOXICILLI N BY SPECTROPHOTOMETRIC METHOD USING POTASSIU M CAROATE
DOI:
https://doi.org/10.32689/2663-0672-2025-4-14Keywords:
oxidation, kinetic-spectrophotometry, validation, potassium caroate, amoxicillin.Abstract
Despite the fact that many different physicochemical methods are used in the practice of analysis, the task of improving known and developing new methods for quantitative determination of penicillins remains relevant in the future. Existing pharmacopoeial methods for determining drugs of this series are quite complex, time-consuming, and require the use of sophisticated, expensive equipment. The disadvantage of the known, fairly simple methods for spectrophotometric determination of penicillins, which are reduced to determining the final products of their hydrolytic cleavage, is the need for prolonged heating. Aim: development of new improved unified method for the quantitative determination of Amoxicillin (Amox). 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. Using the method of kinetic spectrophotometric, procedure for the quantitative determination of Amox in the substance and the drug product have been developed using potassium caroate as an analytical reagent (KHSO5). Results and discussion. A unified methodology was developed and the possibility of qualitative determination of Amox in pure substance and drug using potassium caroate was investigated by kinetic-spectrophotometry. The scheme of the chemical transformation of Amox with the reaction of potassium caroate has been proposed. The kinetic of the conjugated reactions of S-oxidation and perhydrolysis of Amox with potassium caroate in alkaline medium is studied by the increase of forming product light absorbance at 296 nm. The appearance of a new wave gives the possibility of developing a new procedure for the quantitative determination of Amox. The reaction rate was monitored spectrally and display in real time. A differential variation of the tangent method was used to process the kinetic data. Conclusions. Using the kinetic-spectrophotometry method, a method for the quantitative determination of amoxicillin in the substance was developed and the drug product have been developed using potassium caroate as an analytical reagent (KHSO5). The developed method of quantitative determination of Amox 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.
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