Development and Evaluation of Robust RP-HPLC Method for Gliclazide Estimation Integrating Box Behnken Design

[...]generation drugs are equally effective in lowering blood glucose concentrations1. [...]in the present work chromatographic method along with Quality by Design (QbD) approaches been reported to study robustness of the developed method. DoE offers maximum information about how the factors influence the response while requiring minimum time that further can facilitate process of method transfer protocol from transferring to receiving site12-15. [...]in the present study, experimental design is integrated to study influence of the simultaneous variation of different variables for a response to understand the robustness of the method. From results of ANOVA and analysis of response surfaces plots; it can be concluded that responses peak area and retention time are robust for all the three factors mobile phase composition, flow rate and pH of the buffer within selected range.