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IP India · live recordAbstract
The present application relates to process for the preparation of Selumetinib. The present application also relates to the process for the preparation of Selumetinib intermediates. The present application also relates a novel compounds of formulae i.e. a compound Formula (IV), a compound of Formula (V) and a compound of Formula (Va)
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1) A process for the preparation of Selumetinib intermediate of Formula (VI), comprising the steps of: Formula (VI) (a) reacting a compound of Formula (II) with a compound of Formula (III) to give a compound of Formula (IV); Formula (II) Formula (III) Formula (IV) (b) reducing a compound of Formula (IV) to produce a compound of Formula (V). (c) cyclization of compound of Formula (V) to produce a compound of Formula (VI). DocuSign Envelope ID: 11FCB74B-FFDA-4931-851C-BB5EEA621111 16 2) The process according to claim 1, the reducing agent is selected from sodium dithionite, sulfur, sodium sulfide, sodium hydrogen sulfide, palladium on carbon, platinum on carbon, Raney Ni, Pd-BaSO4, Pd-CaCO3, Fe, Zn, SnCl2, B2pin2, B2(OH)4 NaBH4, formic acid. 3) The process according to claim 1, the solvent is selected from toluene, xylene, chlorobenzene, tetralin, methanol, ethanol, isopropyl alcohol, n-butanol, 1-propanol, acetone, ethyl methyl ketone, diethyl ketone, methyl isobutyl ketone, C3-C6 ketones, dichloromethane, chloroform, n-pentane, n-hexane, n-heptane, diethyl ether, diisopropyl ether, tert-butyl methyl ether, dibutyl ether, tetrahydrofuran, 1,2-dimethoxyethane, 2-methoxyethanol, 2-ethoxyethanol, anisole, 1,4-dioxane, acetonitrile, propionitrile, C2-C6 nitriles, ethyl formate, methyl acetate, ethyl acetate, propyl acetate, butyl acetate, methyl propanoate, ethyl propanoate, methyl butanoate, ethyl butanoate, dimethyl formamide, dimethylacetamide, Nmethylpyrrolidine (NMP), formamide, acetamide, propanamide, dimethyl sulfoxide and water. 4) A process for the preparation of Selumetinib comprising converting Selumetinib intermediate of Formula (VI), as prepared by a process of the present application to Selumetinib. Dated 28 th day of December 2022 ____________________ Dr. B. Dinesh Kumar Dr. Reddy’s Laboratories Ltd DocuSign Envelope ID: 11FCB74B-FFDA-4931-851C-BB5EEA621111 17 TITLE OF THE INVENTION: “PROCESS FOR THE PREPARATION OF SELUMETINIB AND ITS INTERMEDIATES”