FIELD: medicine.
SUBSTANCE: invention relates to chemical-pharmaceutical industry and medicine. Method of purifying triptorelin comprises dissolving triptorelin in 0.6 % water solution of acetic acid, filtered by way of ultrafiltration, adding isopropyl alcohol to concentration of 2 % by volume and stirred, performing liquid low pressure chromatography on a column with spherical polystyrene, cross-linked with divinyl benzene type LPS-500 using gradient elution of aqueous solution of isopropyl alcohol (IPA) and acetic acid (AA), obtained solution of semi-finished product is subjected to ion-exchange chromatography on a column with sulphoethyl groups on cross-linked polyacrylate grade SPS-Bio SP Sulphopropyl (SPS-bio) with particle size 75 mcm, using gradient elution, performing highly efficient liquid chromatography on a column with reversed-phase sorbent based on silica gel with particles of spherical shape and size of 5 mcm type Kromasil C18, using eluent aqueous solution containing 5 % IPA and 0.25 % AA, obtained fraction of purified product containing more than 98 % triptorelin is subjected to concentration on hydrophobic sorbent with further elution solution containing a mixture of isopropyl alcohol and acetic acid, evaporating the eluate and its freeze drying.
EFFECT: technical result is high output and purity of substance, which has high bioavailability and can be used for making medical preparations.
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Authors
Dates
2016-05-27—Published
2015-03-26—Filed