METHODS AND OBJECTS OF CHEMICAL ANALYSIS ISSN title: "Metody i obʺekty himičeskogo analiza" An international journal devoted to all aspects of Analytical chemistry ISSN 2413-6166 (Online), ISSN 1991-0290 (Print)
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Le Cong H., Boichenko A.P., Drobot А.V., Loginova L.P.

The quantitative determination of 4-aminobutyric acid impurity in drug substance sodium alendronate by micellar thin-layer chromatography

 The method of determination of 4-aminobutyric acid impurity in drug substance sodium alendronate by micellar thin-layer chromatography has been developed. The optimized composition of micellar eluent (0.02 M cetylpyridinium chloride, 0.05 M Brij 35, 5% (v/v) ethanol, рН 2, HCl) allows to reduce in more than 2 times the time of 4-aminobutyric acid determination in comparison with normative method. The digital processing of chromatograms allows to determine quantitatively 4-aminobutyric acid with relative error 10–15 %. For the first time the Giddins model have been used for description of processes in micellar thin-layer chromatography.

Keywords: micellar thin-layer chromatography, 4-aminobutyric acid, sodium alendronate, Giddins model.