Abstract

An HPLC method for Tamsulosin was developed by using a quality by design (QbD) novel concept. QbD has gained importance in recent times due to regulatory requirements in industrial application. Chromatographic separation of Tamsulosin was carried out by using C8column, and mobile phase used was methanol and distilled water (40:60 v/v) for proper separation process. Separation by using water as a solvent is beneficial as it is cost effective process and industrially applicable. In the development of the HPLC method, factors like injection volume, conc. of methanol, the column vent temperature is critical in maintaining. Hence the Box-Behnken optimization model was applied for the main, interaction and quadratic effects of these three factors on the selected response. The effect of these parameters was studied on the tailing factor (resolution). Results were analysed during a surface diagram. Verification of the software-generated result was done by taking six replicates of the run. Finally, the method was validated according to ICH guidelines.

Key words: Tamsulosin; QbD approach; RP-HPLC method; Box-Behnken model; ICH guidelines.