Novel Process For The Preparation Of Form I Of (S) 2 Ethoxy 4 [N (1 (2 Piperidino Phenyl) 3 Methyl 1 Butyl) Amino Carbonyl Methyl] Benzoic Acid (Repaglinide)

Abstract: The present invention directed towards an alternative, simple, economic and industrially feasible process for the preparation of crystalline Form-I of Repaglinide of Formula-I, which is simple, non-hazardous and commercially viable process. The process comprises the dissolution of the crude Repaglinide in a solvent chosen from the list comprising C1-C5 alcoholic solvents such as ethanol, methanol, propanol, ter- butanol, n-butanol, isopropanol or ketone solvents such as acetone, diethyl ketone, methyl isobutyl ketone, methyl ethyl ketone or ether solvents such as tetrahydrofuran or other solvents like ethyl acetate, acetonitrile at ambient temperature, followed by addition of suitable anti solvent chosen from a list comprising ether solvents, such as methyl tert- butyl ether, isopropyl ether or hydrocarbons solvents, such as o-xylene, n-heptane, n- hexane or petroleum ether or water. The process of the present invention is simple, non-hazardous and commercially viable.

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