An improved process for the purification of perindopril

• Main Authors: DHAKE, VILAS NATHU, TAMBE, SUHAS GANPAT, RANANAWARE, UMESH BABANRAO, NEHATE, SAGAR PURUSHOTTAM, GODBOLE, HIMANSHU MADHAV, SINGH, GIRIJ PAL
• Format: Patent
• Language: English
• Published: 30.10.2009
• Subjects: CHEMISTRY; HETEROCYCLIC COMPOUNDS; METALLURGY; ORGANIC CHEMISTRY

Disclosed is a process for the purification of perindopril, comprising: (i) treating perindopril with dicyclohexylamine in the presence of a solvent to form a salt of perindopril with dicyclohexylamine, (ii) isolating said dicyclohexylamine salt of a compound of formula (I), and (iii) treating the dicyclohexylamine salt of compound of formula (I) optionally in the presence of an organic solvent to form a salt with tert butyl amine, then, optionally, (iv) isolating compound of formula (I) with unknown impurities, and (v) converting to a dicyclohexylamine salt of compound of formula (I) with high purity. Also disclosed is another process for the purification of perindopril, comprising: (i) treating perindopril in a solvent with dicyclohexylamine to form a compound of formula (I) in the form of a salt with dicyclohexylamine, (ii) isolating said dicyclohexylamine salt of perindopril, (iii) treating perindopril in the form of a salt with dicyclohexylamine with an acidic agent to form perindopril free base, and (iv) isolating perindopril free base. Also disclosed is a dicyclohexylamine salt of perindopril.