Abstract

SYNTHESIS, CHARACTERIZATION AND DEVELOPMENT OF VALIDATED RP-HPLC METHOD FOR THE ESTIMATION OF PROCESS-RELATED IMPURITY DIETHYL 4-(4-CHLOROPHENYL)- 2, 6-DIMETHYL-1, 4-DIHYDROPYRIDINE-3, 5-DICARBOXYLATE FROM AMLODIPINE BULK AND FORMULATION

Poonam P. Patil*, Veena S. Kasture and K. Vinitha Prakash

Abstract

The research subscribed in this article is directed towards the identification of process related impurities from Amlodipine drugs and formulation. The identified impurities are then synthesized and the structure of the same was established using FTIR, 1H-NMR, 13C-NMR, GCMS and elemental analysis. After structural establishment of the synthesized impurity a RP-HPLC method was developed for the identification and quantitation of process related impurity diethyl 4-(4- chlorophenyl)-2, 6-dimethyl-1, 4-dihydropyridine-3, 5-dicarboxylate from Amlodipine bulk and formulations. The impurity was synthesized using Hantzsch pyridine synthesis method.

Keywords: Impurity, Hantzsch synthesis, validation, ICH guidelines.