A rapid, specific UV spectrophotometric method has been developed using a solvent methanol to determine Tofisopam content in bulk and pharmaceutical formulations. At a pre-determined wavelength at 310 nm, it was proved linear in the range of 4-24 μg/ml and exhibited good correlation coefficient (R2=0.9996) and excellent mean recovery (98-102%). The method was validated statistically and parameters like linearity, precision, accuracy, specificity, and assay were studied according to International Conference on Harmonization guidelines. The obtained results proved that the method can be employed for the routine analysis of Tofisopam in bulk as well as in the commercial formulations.
A novel, simple, optimized reversed-phase chromatography method for assay of Tofisopam in pure and tablet form is developed. The experimental trial was by Box Behnken design using the Design Expert® software 10 version. The attributes selected were peak symmetry, number of theoretical, and peak purity. The predicted data satisfied with actual experimental data. The optimized chromatographic conditions required a quaternary pump with a mobile phase of Water: Acetonitrile 25:75 v/v at 1 mL/min, oven temperature at 25oC at 310 nm using C18(250 × 4.6 mm Id, 5μm) column and PDA detector with a run time of 5 min. The method was validated for linearity, precision, accuracy, and specificity. The method produced a linear response over a concentration range of 4–24 ppm with an overall average accuracy of 99.98%. The method was robust, reproducible, and specific with respect to the retention time of tofisopam.
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