OBTAINING LATANOPROSTENE BUNOD OF REQUIRED QUALITY PRESET BY CHROMATOGRAPHY WITH GRAVITATIONAL ELUTION Russian patent published in 2020 - IPC C07C405/00 B01D15/08 

FIELD: chemical or physical processes.

SUBSTANCE: present invention relates to a method of producing latanoprostene bunod of formula (I)

consisting in that crude latanoprostene bunod of formula (I) is purified by chromatography using column chromatography on normal-phase silica gel with gravitational elution using silica gel: a.) of silica gel for normal phase with particles of irregular shape with particle size of 63–200 microns or b.) of silica gel for normal phase with particles of spherical shape with particle size of 50–150 microns, and as eluent—mixture of eluents consisting of non-polar and polar solvents, and if necessary impurities arising from eluents, which are used for purification chromatography of compound of formula (I), removed by filtration chromatography on silica gel. Produced latanoprostene bunod meets the following technical requirements for quality:

Latanoprostene bunod Related impurities (HPLC) 15S-Latanoprostene bunod ≤ 0.5 0% 5,6-trans-Latanoprostene bunod ≤ 3.5 % Latanoprost ≤ 0.50 % Latanoprost acid ≤ 0.50 % Unidentified impurities separately ≤ 0.10 % Unidentified admixtures, total ≤ 0.30 % Sum of impurities ≤ 5.0 %

See the tab.

EFFECT: disclosed is production of required amount of preset quality latanoprostene bunod by chromatography with gravitational elution.

13 cl, 23 tbl, 17 ex