Central composite design (CCD) based RP-HPLC method optimization for the synchronized analysis of Efonidipine Hydrochloride Ethanolate (EFE) and Chlorthalidone (CHL) in Tablet. The effective separation was performed using Inertsil ODS C18 column (250 x 4.6 mm,5μm), PDA detector with 0.05M KH2PO4 Buffer (pH 4.5): Acetonitrile (40:60%v/v) mobile phase. Independent variables were investigated include the concentration of KH2PO4 (X1) and flow rate of mobile phase (X2). Based on responses obtained (retention time, resolution and tailing factor), the optimum condition selected was X1 = 40% and X2 = 1 ml.ml-1. Optimized HPLC condition was validated by assessing validation parameters and it meet the acceptance criteria set by ICH. It was showed linear calibration curve in the quantity range 6.25-18.75 μg.ml-1 and 20-60 μg.ml-1. % for CHL & EFE. Assay of drugs was 100.94% and 100.06% for CHL & EFE. The validated RP-HPLC-PDA method can be used for routine analysis of EFE and CHL in tablet.
doi.org/10.32737/0005-2531-2024-2-26-35
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