CRYSTALLINE MONTELUKAST SODIUM SALT OF HIGH PURITY HAVING IMPROVE FILTERING PROPERTY AND A METHOD FOR PREPARING THE SAME

摘要

PURPOSE: A crystalline montelukast sodium salt of high purity and a method for preparing the same are provided to obtain the montelukast sodium salt having excellent crystalline and stability.;CONSTITUTION: A crystaliine montelukast sodium salt has 10% or more peak intensity at 5.37, 8.08, 16.22, 16.69, 20.33, 20.71, 21.64, 24.78, and 25.60 diffraction(2&thgr;±0.1) in X-ray diffraction analysis. A method for preparing the crystalline montelukast sodium salt comprises: a step of dissolving montelukast free acid and sodium-containing base in a polar organic solvent to obtain a first solution; a step of adding anti-solvent to the first solution and stirring to obtain a seed-bed suspension; a step of repeating the step of preparing the first solution to obtain a second solution; a step of adding the second solution and half-solvent to the seed-bed suspension; and a step of filtering and drying. The half-solvent is n-pentane, n-hexane, n-heptane or n-octane.;COPYRIGHT KIPO 2010