Development and validation of a RP-HPLC method for simultaneous estimation of Olmesartan Medoxomil and Amlodipine Besylate in tablet dosage form

By Aniruddha R. Chabukswar, Bhanudas S. Kuchekar, Swati C. Jagdale, Dipali M. Mehetre, Archana S More and Pradeep D. Lokhande


A simple, precise, rapid and accurate RP HPLC method has been developed for the simultaneous estimation of olmesartan medoxomil and amlodipine besylate in tablet formulations. The chromatographic separation was achieved on a Waters Symmetry C18 column (250 mm x 4.6 mm, 5.0 µ particle size) using Acetonitrile: Methanol: water (60: 28: 12 v/v/v) mobile phase. Ortho-phosphoric acid was used to adjust pH to 3.2, flow rate was 0.6 ml/min and column was maintained at 300C. Quantification and linearity was achieved at 254 nm over the concentration range of 2 to 128µg /ml for olmesartan medoxomil and 0.5 to 32µg/ml for amlodipine besylate.  The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness.

Key words: Amlodipine besylate, Olmesartan medoxomil, RP HPLC, Validation, Formulation

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