FIELD: analytical chemistry.
SUBSTANCE: disclosed is a method for determining carbohydrate stabilizers in biologically active drugs by ion-exchange high-performance liquid chromatography with pulsed amperometric detection, comprising dilution containing at least one carbohydrate stabilizer in a biologically active drug and initial standard solution with concentration of 1.0 mg/l to concentration of carbohydrate stabilizers from 10 to 50 mcg/ml and from 1 to 50 mcg/ml, respectively, or from 25 to 120 mcg/ml and from 2 to 120 mcg/ml, respectively, the obtained solutions are chromatographed in an isocratic elution mode, where the mobile phase is in form of sodium hydroxide or potassium hydroxide with concentration of 160 mmol/l, and then calculations are carried out.
EFFECT: invention provides a method for determining carbohydrate stabilizers in biologically active drugs by ion-exchange high-performance liquid chromatography (ion-exchange HPLC) with pulsed amperometric detection.
7 cl, 16 dwg, 4 tbl, 12 ex
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Authors
Dates
2024-03-25—Published
2023-07-12—Filed