Stability indicating HPTLC method development and validation of evogliptin in bulk and tablet dosage form by using a QbD approach.

This study explains the well-structured development and validation of the HPTLC method and the qualitative evaluation of Evogliptin in both bulk and tablet formulation using the quality by design (QbD) approach. Chromatographic separation was carried out on an aluminium-backed silica gel F₂₅₄ plate using a mobile phase consisting of ethyl acetate :methanol: triethylamine (6:4:0.1 V/V/V). Densitometry was carried out at a wavelength of 267 nm. The band corresponding to the Evogliptin was obtained at R_f=0.39. The method was found to be linear, with r²=0.9961. The critical analytical attributes (CAAs) for the HPTLC method were identified. The saturation time, band length and solvent front were determined as critical method parameters (CMP) and extensively optimized employing Box-Behnken Design (BBD), with a focus on the retention factor (R^f) value as the CAA. The method described in this study exhibited linearity. The accuracy, precision, linearity, LOD, LOQ and robustness values were within the specified limits. The developed method was validated according to ICH guidelines and the results were found to be within the acceptance criteria. This study effectively demonstrates the value of the QbD approach for creating an incredibly accurate HPTLC method with improved system effectiveness. [ABSTRACT FROM AUTHOR]