abstract |
A process for the preparation of crystalline rosiglitazone maleate Form A which is characterized by having an X-ray diffraction pattern with the following characteristic peaks (2θ): 9.5, 15.86, 15.02, 17.00, 18.52 , 21.99, 23.58, 25.06 and 26.55, the method comprising the preparation of a mixture comprising rosiglitazone in free base form and maleic acid present in a water-miscible solvent, stirring the mixture and heating it to produce a solution, filtering to produce a clear filtrate and adding a water-immiscible solvent, followed by stirring and cooling to isolate crystalline Rosiglitazone maleate Form A |