Selection of optimal parameters for the analysis of dioxoindolinone by the method of high pressure liquids chromatography

Abstract

Introduction. Dioxoindolinone – (1'-(2-oxo-propil)-spiro[[1,3]dioxolane-2',3'-indolin]- 2'-one) – is a new native compound of the isatin group, synthesized in the Organic Synthesis and Biopharmaceutical Laboratory of the Institute of Chemistry. The substance has anti-depressive and sedative activity and is researched in order to develop methods of analysis and standartization. Purpose. Selection of chromatographic parameters for the elaboration of the method of analysis of Dioxoindolinone (1 '- (2-oxo-propyl) -spiro [[1,3] dioxolane-2', 3'-indoline] -2'-one), by HPLC method. Material and methods. Dioxoindolinone, experimental synthesis series; and possible specific impurities (izatine – initial synthetic substance, ketal izatine – intermediate product )were assessed; Shimadzu LC-20AD liquid chromatograph with UV-detector SPD-20A, solvents and reagents in accordance with the requirements of the European Pharmacopoeia. Results. The research allowed to select the optimal conditions for the analysis of Dioxoindolinone by HPLC method: mobile phase – methanol: water: phosphoric acid solution 0.1% (40:20:40), Zorbax Eclipse Plus C18 column, 5 μm, 4.6 x 250 mm; UV-VIS detector, wavelength 258 nm., column temperature 30 0C, beginning of the mobile phase 1.2 mL / min, injection volume 20 μl. The retention times were: for Dioxoindolinone – 6.5 min.; for izatine – 4,3 min.; for ketal izatine – 7,11 min. Conclusions. The selected chromatographic conditions and mobile phase offer possibilities for the elaboration of the method for the determination of related substances in Dioxoindolinone, as well as its assay.