Development and Validation of HPLC Assay Method of Tofisopam by QBD Approach

The aim of the present work is to develop and validate novel, simple, optimized reversed phase chromatography method for assay of Tofisopam in pure and tablet form. Quality by design (QBD) refers to the achievement of certain predictable quality with desired and predetermined specifications. The QbD approach emphasizes product and process understanding with quality risk management and controls, resulting in higher assurance of product quality, regulatory flexibility, and continual improvement. The experimental trial was by Box Behnken design using Design Expert® software 10 version. The attributes selected were peak symmetry, NTP and peak purity. The predicted data satisfied with actual experimental data. The experimental design suggested the robust MODR region for the TF HPLC method development. All the validated parameters were within the acceptable criteria of ICH guidelines. The optimized chromatographic conditions required quaternary pump with mobile phase of Water: Acetonitrile 25:75 v/v at 1 ml/min, oven temperature at 25oC at 310 nm using C18 (250 X 4.6 mm Id, 5 m) column and PDA detector with a run time of 5 min. In this investigation, three independent variables-peak symmetry, retention time, and NTP-were used to determine the concentration of the organic phase, oven temperature, and flow rate. The linearity method, precision, accuracy, and specificity were all verified. With an overall average accuracy of 99.98%, the approach provided linear responses spanning the concentration range of 4 to 24 ppm. Regarding the tofisopam retention time, the approach was reliable, repeatable, and precise.