Method Development and Validation of Amlodipine Besylte, Hydrochlorothaizidine and Olmesartan Medoxomil Combined Dosage Form

Abstract

This paper describes validated high-performance thin-layer chromatography (HPTLC) method for the Simultaneous estimation of Amlodipine Besylate (AMLO), Hydrochlorothiazide (HCTZ) and Olmesartan Medoxomil (OLM) in bulk and combined Tablet Dosage form. The SFC method the chromatographic condition is optimized by fixing parameters as Agilent ZORBEX SB Phenyl 150*4.6 mm, 5µm particle size with mobile phase as co2 and Methanol. Mobile phase flow rate was CO2 (1.25ml/min) and Methanol (0.25ml/min) and detected at 237nm. Temperature of column is 35°C and Back pressure is 200 bar. Quantification was achieved with ultraviolet (UV) detection at 237 nm. The HPTLC separation was achieved on Precoated silica gel 60gf254 using Toluene: Chloroform: Methanol: Acetonitrile: Formic acid 11.6% (2:7:1.8:0.4;0.4, v/v/v/v) as the mobile phase. Quantification was achieved with UV detection at 232 nm.. All the two methods were validated as per ICH guidelines. The proposed methods for estimation of AMLO, HCTZ and OLM were found to be simple, precise, and accurate are applicable for the simultaneous determination of AMLO, HCTZ and OLM in marketed tablet formulations.