METHOD OF SIMULTANEOUS DETERMINATION OF IMPURITIES OF ETHYLENDIAMINTETRAUXUS ACID, DIMETHYLSULPHOXIDE AND N-ETHYLMALEMIMIDE IN PHARMACEUTICAL SUBSTANCES BY THE METHOD OF CURED-PHASE HIGH-EFFECTIVE LIQUID CHROMATOGRAPHY

摘要

FIELD: chemistry.;SUBSTANCE: method of simultaneous determination of the impurities of ethylenediaminetetraacetic acid (EDTA), dimethylsulfoxide (DMSO) and N-ethylmaleimide (ETM) in pharmaceutical substances by reversed-phase high-performance liquid chromatography involves the determination of EDTA, DMSO and ETM during one analysis, using a chromatographic column length no more 150 mm, filled with a carrier with a grain size of not more than 5 mcm, using an acid solution of orthophosphoric 10-30 mM (PH 1.9-2.26) with a gradient of organic solvent from 0 to 100%, at a column temperature of 25-45°C, the detection limit for EDTA is from 4.14 to 8.0 ng, DMSO is from 0.8 to 3.0 ng, ETM is 0.04 to 1 ng, and the limit for the quantitative determination of EDTA is from 12.9 to 30 Ng, DMSO - from 2.66 to 10 ng, ETM - from 0.13 to 3 ng.;EFFECT: improving the accuracy.;30 dwg, 11 tbl, 6 ex