Development and validation of UV spectrophotometric method for estimationof process related impurity in felodipine bulk and formulation

[摘要] 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.

[学科分类] 药理学