| abstract |
The present invention describes one pot process for the preparation of amorphous atrovastatin calcium by treating solution of ATV-1 in a water miscible polar organic solvent with an aqueous acid, neutralizing and hydrolyzing at a temperature ranging between 40°c to 55°c using aqueous alkali hydroxide, removing the polar solvent under vacuum to reduce the volume to one fourth, adding water, methanol and methyl-t-butylether, stirring, separating the aqueous layer, extracting further aqueous layer with ethyl acetate-n-hexane mixture, collecting aqueous layer after extraction, adjusting the pH between 7.5 to 8.5, stirring at a temperature between 40°-55°C, adding aqueous calcium acetate solution in portions, seeding with amorphous atorvastatin calcium, cooling to obtain amorphous atorvastain calcium having required purity and enhanced yield. |