A MANUFACTURING METHOD OF ESAMLODIPINE BESILATE AND ITS HYDRATE

摘要

PURPOSE: A method for preparing S-amlodipine besilate and hydrate thereof is provided to ensure optical and chemical purity and to use the compounds for treating cardiovascular diseases. CONSTITUTION: An S-amlodipine besilate hydrate is prepared by vacuum-drying the S-amlodipine besilate salt at 30-65°C. A method for preparing S-amlodipine besilate comprises: a step 1 of suspending or dissolving S-amlodipine in ethanol; a step 2 of dissolving benzene sulfonic acid in ethanol and adding a first mixture of step 1 to prepare a second mixture at 20-25°C; a step of adding water to the mixture of step 2 to prepare a crystal; a step of filtering, washing, and drying the crystal.