నైరూప్య

Identification and characterization of impurity in olmesartan medoxomil bulk drug

S.G.Hiriyanna, K.Basavaiah, Hari N.Pati, Bijay K.Mishra

Olmesartan 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.