DEVELOPMENT OF HPLC METHOD FOR DETERMINING THE FOREIGN IMPURITIES IN THE SUBSTANCE OF CARBORENAbstract
A High-Performance Liquid Chromatography (HPLC) technique has been developed for the determining of foreign impurities in the parent substance of carboren. We have proposed the most sensitive, selective and also the universal HPLC method to be used, which would allow to conduct the qualitative and quantitative analysis under the same conditions so that to determine foreign impurities in the substance. Reliable separation of carboren and impurities was performed on a liquid chromatography equipped with a spectrophotometric detector and an analytical stainless steel column (250 × 4, 6 mm) of size, filled with C18 sorbent (5m km), in gradient elution mode. The detection of limits for carboren and identified of potential organic impurities were determined. It was found that the content of any other individual impurity did not exceed 0.1%, the total content of impurities did not exceed 0.5%. In the samples, impurities A, B and C were detected with a relative retention time of 0.35; 0.42 and 0.30. The results were repeatedly reproduced in model mixtures, parent substance samples.
N. L. Bereznyakova *, S. V. Baiurka, A. V. Berezniakov, V. D. Yaremenko and L. A. Bobritskaya
Department of Medicinal Chemistry, National University of Pharmacy, Kharkiv, Ukraine.
18 October, 2017
19 December, 2017
25 December, 2017
01 July, 2018