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Olmesartan Medoxomil (OLME) belongs to a group of angiotensin II receptor  blockers used as an antihypertensive agent and is currently being used for  prevention of Hypertension. This paper describes the Validation and  development of stability indicating RP-HPLC method for the determination of  OLME in the presence of its degradation products generated from forced  degradation study and characterization of degradation product (impurity). The  assay involved gradient elution of OLME on An LC GC BDS C18 column (250 ×  4.5mm, 5-μm particle size) was employed for loading the sample. The mobile  phase A consists of 7 ml Triethylamine in 1000 ml water (pH adjusted to 3.0  with orthophosphoric acid) and B contains acetonitrile. Quantification was  achieved with photodiode array detection at 257 nm. The chromatographic  separation was obtained with a retention time of 6.72 min, and the method was  linear in the range 50-150 µg/ml. The method was validated according to the  ICH guidelines with respect to linearity, precision, accuracy, limit of  detection (LOD), limit of quantification (LOQ), specificity and robustness.  Impurity found in stressed and stability studies of Olmesartan Medoxomil in  both drug substance and drug product are described. This degradation product  is identified as 1-(biphenyl-4-ylmethyl)-1H-imidazole-5-carboxylic acid. An  Alkaline degradation pathway of Olmesartan medoxomil, for the formation of  this degradation product, has been proposed and degradation product was  characterized

chemical industry and chemical engineering quarterly

Development and validation of stability-indicating RP-HPLC method for determination of Olmesartan medoxomile in pharmaceutical dosage form and identification, characterization of alkaline degradation impurity of Olmesartan medoxomile drug substance as well as drug product