AN IMPROVED PROCESS FOR THE PREPARATION OF ALPHA FORM OF IMATINIB MESYLATE

摘要

An improved process, which is simple, convenient, economical and industrially viable, for the preparation of stable, free flowing, non-hygroscopic crystalline alpha form of Imatinib mesylate, free from the beta form. The process comprises a) providing a clear solution of imatinib base in organic solvent; b) optionally, filtering the solution to remove any insoluble impurity; c) adding another organic solvent to the solution of step (b) and heating to obtain a clear solution; d) adding solution of methane sulfonic acid in second organic solvent slowly to the solution of step (c) on heating; e) cooling of the reaction mixture obtained in step (d) followed by seeding of the clear solution with pure alpha crystalline form of Imatinib mesylate on heating; f) slowly cooling of the reaction mixture; g) isolating the imatinib mesylate alpha form; wherein the organic solvent is selected from the group comprising of N, N-dimethyl sulphoxide, Isopropanol and mixtures thereof.