FIELD: measuring.
SUBSTANCE: invention relates to the analytical and pharmaceutical industry, namely, to determining the residual quantities of sodium 4,4′-(propanediamido)dibenzoate in biological fluids when establishing pharmacokinetic parameters and determining the therapeutic dose of the medicinal product. Method for quantifying sodium 4,4′-(propanediamido)dibenzoate in biological objects includes sampling, analysis, and processing of the results of analysis, wherein the quantification is conducting using high-efficiency liquid chromatography, and a mass spectrometric detector is used as a detector. Mass chromatograms are recorded in negative ionisation in the mode of selected ions at m/z=341, chromatography is performed on a Zorbax Plus CN column 150 mm in length with a 4.6 mm internal diameter and a particle size of 5 mcm, at a mobile phase flow rate of 0.3 ml/min and a volume of the input sample of 20 mcl. The mobile phase consists of a mixture of acetonitrile and a 1.0% formic acid solution in a 30:70 ratio. The concentration of sodium 4,4′-(propanediamido)dibenzoate is found using a calibration graph.
EFFECT: method allows determining sodium 4,4′-(propanediamido)dibenzoate in the concentration range from 2.00 to 100.00 ng/ml with high sensitivity and stability.
1 cl, 1 tbl, 3 ex
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Authors
Dates
2022-10-04—Published
2021-06-16—Filed