PROCESS FOR THE PREPARATION OF OPTICALLY PURE R (-) SALBUTAMOL AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS

摘要

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.