DETERMINATION OF POLYSORBATE 80 IN BIOLOGICAL MEDICINAL PRODUCTS Russian patent published in 2024 - IPC G01N30/06 G01N30/74 G01N30/34 

FIELD: biological medicinal products.

SUBSTANCE: invention relates to the determination of excipients contained in biological medicinal products. The following is disclosed: a method of the quantitative determination of polysorbate 80 in biologically active medicinal products selected from a conjugate adsorption vaccine, a combined vector vaccine, recombinant blood factor VIII, using size exclusion high-performance liquid chromatography, including dilution of biologically active drugs and the original standard solution of polysorbate 80 with a concentration of 1 mg/ml with water and the mobile phase, respectively, to a concentration of polysorbate 80 in them from 0.02 to 0.2 mg/ml, then chromatographed using the mobile phase, an ultraviolet detector in isocratic mode at a wavelength of 234 nm with a flow rate of 1.0 ml/min, then quantitative determination of polysorbate 80 is carried out, while the mobile phase is a phosphate buffer with a concentration of 0.1 M and pH 6.7 containing 0.1 M sodium sulphate, 0.1% sodium dodecyl sulphate, 0.05% sodium azide.

EFFECT: invention provides an accurate and sensitive method of determining polysorbate 80 by size exclusion HPLC with UV signal detection in biologically active drugs.

4 cl, 2 dwg, 3 tbl, 7 ex