ISSN : 2663-2187

METHOD DEVELOPMENT AND VALIDATION OF OLMESARTAN, CHLORTHALIDONE AND AMLODIPINE IN TABLETS DOSAGE FORMS BY USING RP-HPLC METHOD

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Kundan Deore, Ujash Shah
» doi: 10.33472/AFJBS.6.Si2.2024.1563-1575

Abstract

A simple, accurate, precise and robust RP-HPLC method has been developed and validated for the simultaneous estimation of Olmesartan Medoxomil (OLM), Chlorthalidone (CHL) and Amlodipine (AML) in their combined tablet dosage form. The combination used for the Separation is Triolmesar CH 40. Separation was performed on a C18 column (4.6mm × 250 mm; 5 μm), with acetonitrile: 0.1% OPA pH 4.2 with TEA (60:40 V/V) flowing at 1 ml/min. Good sensitivity was found with UV detection at 254 nm. After method development the interference with the active compounds and excipients, repeatability and linearity were investigated. Retention times were found to be 2.30 min, 5.68 min, and 9.05 min. respectively, for OLM, CHL and AML. The method was validated over the analytical range from 40-200 µg/ml for OLM (r2=0.9996), 12.50-62.5 µg/ml CHL(r2=0.9996) and 5-25μg/ml for AML(r2=0.9999). This method showed good reproducibility and recovery with %RSD in the desired range. The proposed method can be successfully applied for the routine analysis of the OLM, CHL and AML drugs in their combine dosage form.

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