DoE based development and validation of HPTLC method for simultaneous estimation of Curcumin and Naringin in topical gel formulation.

A rapid, accurate, precise, sensitive, and robust HPTLC method was developed for the simultaneous estimation of curcumin and naringin from the standard mixture and topical gel formulation. Quality by Design-based development of HPTLC method was carried out. The factor screening was performed using a seven-factor eight-run Taguchi design. The content of toluene in the mobile phase, saturation time and distance travel were selected as critical method parameters from screening studies. The Box-Behnken design was employed for systematic optimization of critical parameters and evaluating the robustness of the method. The data obtained from screening design and optimization design were analysed statistically and graphically to derive the conclusion. The optimal HPTLC separation was achieved using toluene:acetonitrile:methanol (5:3:2 v/v/v) as mobile phase with a bandwidth of 6 mm, saturation time of 25 min and distance travel up to 80 mm and scanning slit dimension of 4.00×0.30 mm. The chromatogram was scanned at 420 nm for curcumin and 286 nm for naringin. The method was validated for linearity, specificity, precision, accuracy, limit of detection, limit of quantitation and robustness according to ICH guidelines. The developed method was successfully employed for estimation of curcumin and naringin in topical gel formulation. [ABSTRACT FROM AUTHOR]