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AssigneeUSV Limited
InventorsVenkatasubramanian Radhakrishnan Tarur, Suresh Mahadev Kadam, Anil Purushottam Joshi, Sachin Baban Gavhane
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The present invention discloses a process for the synthesis of N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulphonyl]-2-hydroxy-2-methyl propanamide (Form I). The invention discloses a reagent for oxidation of N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)thio]-2-hydroxy-2-methyl propanamide to N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulphonyl]-2-hydroxy-2-methyl propanamide. More particularly, the invention discloses a method of purification of N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulphonyl]-2-hydroxy-2-methyl propanamide in a mixture of methylethyl ketone and hexane giving form (I). This form (I) is useful as an active pharmaceutical and has antiandrogenic activity.
1) A process of preparation of Bicalutamide Form I comprising oxidation of N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)thio]-2-hydroxy-2-methyl propanamide of Formula (VII) with sodium perborate trihydrate in presence of a solvent.
6) A process of obtaining a substantially pure Bicalutamide comprising precipitating Bicalutamide (form I) from a solution containing Bicalutamide.
13) A process for the preparation of Bicalutamide and its purification as substantially described herein with reference to the foregoing examples 1-2.
Dependencies are inferred from the claim text.