DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE, CILNIDIPINE IN COMBINATION TABLET DOSAGE FORM
Keywords:HPLC, Acetonitrile, Olmesartan, Amlodipine, Cilnidipine
Objective: To develop and validate a simple, sensitive and isocratic reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous determination of olmesartan medoxomil (OLM), amlodipine besylate (AML) and cilnidipine (CIL) in pharmaceutical tablet formulation.
Methods: In this work we have taken 2 combinations, combination 1-OLM & AML and combination 2-OLM & CIL. HPLC analysis was carried out by using reverse phase isocratic elution with a C 18 column and a mobile phase of 0.05 M ammonium acetate, acetonitrile and methanol in the ratio of 30:50:20, v/v, pH was adjusted to 7.3. Detection of the analyte was achieved by using UV detector at 240 nm.
Results: The retention time of olmesartan medoxomil, amlodipine besylate and cilnidipine were 2.2, 3 and 4.5 minutes respectively. Linearity of the method was found to be in the concentration range of 10-100Âµg/ml for olmesartan medoxomil, 5-50Âµg/ml for amlodipine and 10-100Âµg/ml for cilnidipine. The correlation coefficient value was greater than 0.999 for all the analytes.
Conclusion: The method was validated as per ICH guidelines and is applied for the estimation of these components simultaneously in pharmaceutical tablet formulation.
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