Abstract
Identification and characterization of impurity in olmesartan medoxomil bulk drug
Author(s): S.G.Hiriyanna, K.Basavaiah, Hari N.Pati, Bijay K.MishraOlmesartan medoxomil is an angiotensin II antagonist and is used as antihypertensive agent. Impurity profiling of olmesartanmedoxomil drug substance by reverse phase HPLC reveals the presence of a potential impurity. It was isolated by preparative liquid chromatography(Prep LC) and structural characterization was done by NMR and FT-IR. Further characterization was done on the basis of fragmentation pattern of this impurity by LC-MS/MS using Electron Spray Ionization (ESI) source and triple quadrapole mass analyzer. This impurity is characterized as 5-methyl-2- oxo-[1,3]dioxo-4-ylmethyl-4-(1-methoxy-1-methyl-ethyl)-2-propyl-1-{4- [2Â’(1H-tetrazol-5-yl)phenyl] phenyl}methyl imidazole-5-carboxylate.
