Development and Validation of Spectrophotometric Method for the Determination of Tofisopam in Bulk and Pharmaceutical Formulation

Abstract

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.