BigPatents India

A process for the preparation of optically pure R (-) salbutamol of formula (6) and its pharmaceutically acceptable salts by using a (+)4-nitro tartranilic acid as the resolving agent and a binary solvent system comprising alkyl acetate and C1 to C4 branched or normal chain alcohol for dissolution of the racemic mixture and resolving agent and purification of the 4-nitro tartranilic acid salt of R (-) salbutamol. 4-nitro tartranilic acid salt of R (-)salbutamol is converted into formic acid salt of R (-) 4-benzyl salbutamol followed by basification and debenzylation to form optically pure R (-) salbutamol. Optically pure (R) -salbutamol is obtained in good yield and high purity. The optically pure R(-) salbutamol is optionally converted into pharmaceutically acceptable salts. No. of Pages : 21 No. of Claims : 7