Separation of fulvestrant isomers

C - Chemistry – Metallurgy – 07 – J

Patent

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Details

C07J 31/00 (2006.01) A61K 31/565 (2006.01) B01D 15/38 (2006.01) G01N 30/02 (2006.01)

Patent

CA 2619476

The invention encompasses methods of separating the isomers of fulvestrant comprising placing a fulvestrant sample on a HPLC using a reverse phase column or chiral column; eluting the sample with an eluant having a first mobile phase and a second mobile phase; and collecting purified fractions of fulvestrant sulfoxide A or fulvestrant sulfoxide B from the column. The method provides fulvestrant sulfoxide A or fulvestrant sulfoxide B in 99.5% purity as determined by HPLC.

L'invention concerne des procédés de séparation des isomères du fulvestrant comprenant de placer un échantillon de fulvestrant sur un appareil d'HPLC utilisant une colonne à polarité de phases inversée ou une colonne chirale ; d'éluer l'échantillon avec un éluant ayant une première phase mobile et une seconde phase mobile ; et de recueillir des fractions purifiées de sulfoxyde de fulvestrant A ou de sulfoxyde de fulvestrant B en sortie de colonne. Le procédé produit du sulfoxyde de fulvestrant A ou du sulfoxyde de fulvestrant B ayant une pureté de 99,5 % telle que déterminée par HPLC.

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