Research Article
Vaibhav M. Thorat, Pawar S. S.
Abstract
This research is directed towards synthesis and characterization of process related impurity of Felodipine i.e.diethyl 4-(4-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate (FI) in bulk and tablet formulation by UV, IR and NMR techniques and its quantitationby UV spectrophotometric method development. The synthesis of (FI) was carried out by Hantzch process using p-chlorobenzaldehyde, ethylacetoacetate in presence of ammonia and methanol as catalyst. The preliminary evaluation was done on laboratory scale viz. melting point, TLC and elemental analysis. The regression coefficient was found to be 0.999 and Relative Standard Deviations were below 2%. The method was validated as per ICH guidelines and was found to be linear, precise, accurate, robust and rugged.