Abstract

The Quality by design enabled the development of cost-effective, simple, precise, and rapid RP-HPLC techniques for determining Pyridoxine and Doxylamine in the tablet dosage form. Systematic method optimization was performed through central composite design by altering the flow rate and composition of the organic phase in the mobile phase as the critical method parameters for evaluating the necessary analytical attributes, namely the tailing factor, theoretical plate count, and resolution. The optimal separation was achieved on a column with C18 in nature and dimensions of (250 mm length x 4.6 mm id x 5 μm particle size) composed of a blend of acetate buffer and acetonitrile in a volumetric composition of 35:65, at a flow rate of 1.0 mL/min. Detection was carried out at 254nm. The Pyridoxine and Doxylamine has a retention times of 3.053 and 4.357 min, respectively. The developed method was useful for determination of bulk drug and formulations

Key words: Pyridoxine, Doxylamine, Method validation, Quality by design