A. V. Lastovka, V. P. Fadeeva, I. Il’ina
2017
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Abstract
Composition and structure of (2 R ,4 R ,4a R ,7 R ,8a R )-4,7-dimethyl-2- (thiophen-2-yl)octahydro-2 H -chromen-4-ol are determined using elemental analysis, UV-, IR-, NMR 1 H- and 13 C-spectrometry. A number of physicochemical parameters — melting point, molecular weight, “pellucidness,” “chromacity” and pH; humidity (after Fisher) and sulphated ash — are determined. A qualitative determination of the substance is based on the indophenine reaction between thiophene and isatin with sulfuric acid present. A method of quantitative determination of the active sub- stance and validation of the procedure is developed using HPLC. Content of the active substance determined by the proposed method ranges from 99.4 to 100.7%. The detection and quantification limits are 0.78 and 2.4 ì g/ml, respec-tively.