Özet:

The aim of the work. Development of quality control methods, in particular, spectrophotometric determination of the quantitative content of sulfadimidine in the dosage form of Sulfadimidine on the basis of its reaction with 3-α,γ-dycarboxypropilrhodanine, and the developed methods validation. Materials and Methods. Reagents and solvents used in the present study: a standard sample of sulfadimidine, Sulfadimidine tablets (AgroFarm, Ukraine, series 020217) 3-α,γ-dycarboxypropilrhodanine (chemically pure), sodium nitrite and sodium phosphate solutions were prepared by accurately weighed extra pure reagents dissolving, hydrochloric acid solutions were prepared by the extra pure acid concentrated solution diluting. Analytical equipment: Spectrophotometer SF-48, electronic weighing scale RADWAG WPA 40/160/C/1, laboratory glassware of class A. Results and Discussion. The technique of spectrophotometric determination of sulfadimidine quantitative content in the dosage form of Sulfadimidine based on its reaction with 3-α,γ-dycarboxypropilrhodanine was developed. The stoichiometric ratios of the reactive components as 1:1 were obtained by the methods of continuous changes and the saturation method. The technique validation allowed confirming its linear fit, high precision, accuracy and robustness which proved the possibility of its application in quality control departments of chemical and pharmaceutical industry companies.Conclusions. The interaction reaction between the preliminary diazotized  sulfadimidine with 3-α, γ- dycarboxypropilrhodanine was investigated which resulted in a colored azo compound obtaining. Quantitative spectrophotometric technique was developed for sulfadimidine determination in Sulfadimidine tablets based on this reaction. The developed technique was validated according to such validation characteristics as the linear fit correspondence, range of applicability, precision, correctness and robustness.

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