FIELD: chemistry.
SUBSTANCE: invention relates to a method for determining related impurities in 4,4'-(propanediamido)dibenzoate of sodium, which is carried out by capillary zone electrophoresis, which involves preparation of reference solutions – a solution of related impurities: 4-aminobenzoic acid and 4-(3-oxo-3-ethoxypropanoyl)amino)benzoic acid, and the test solutions – substance and tablets 4,4'-(propanediamido)dibenzoate of sodium, introducing the sample into a capillary electrophoresis system (hydrodynamic sample introduction, 210 mbar×s), carrying out electrophoretic separation with a borate buffer as a lead electrolyte (solution of sodium tetraborate 10-aqueous with concentration 50 mmol/l, quartz column, total column length 60 cm, effective column length 50 cm, inner diameter 75 mcm, applied voltage +20 kV), spectrophotometric detection of peaks at wave length 270 nm and analysis results processing.
EFFECT: disclosed is a method for determining related impurities in a pharmaceutical substance and a ready dosage form of 4,4'-(propanediamido)dibenzoate of sodium by using capillary zone electrophoresis method, to obtain reliable data with reduced time and economic costs for sample preparation and analysis.
1 cl, 3 dwg, 3 tbl, 3 ex
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