Analytical Method Development and Validation of Tofisopam in Pure and Pharmaceutical formulation

Abstract

Tofisopam is an anxiolytic used in treatment of anxiety like disorders, prescribed in the dosage of 50mg to 300mg. As the drug is insoluble in water it is necessary to develop an economical and streamlined liquid chromatography for determination of pure and commercial dosage of Tofisopam. The main objective of the work is to develop and validate an RP-HPLC method for determination of Tofisopam as per ICH guidelines. An RP- HPLC method was devised using 0.1% Orthophosphoric acid in water: methanol in the ration 10:90% v/v and validated for parameters such as system suitability, linearity, limit of detection, limit of quantitation, precision, accuracy, assay, robustness, and ruggedness, as per ICH Guidelines. Tofisopam showed the maximum absorbance at 238nm with good system suitability and linearity was entrenched within the range of 10-60µg/ml, with the regression coefficient of 0.9996. The limit of detection and limit of quantitation were found to be 2.75 µg/ml and 8.855µg/ml respectively. Assay was valuated to be 101%, Accuracy was valuated between 98-103%, and %RSD was less the 2% for precision, robustness and ruggedness, so the method is precise and accurate. The method robustness is demonstrated by insignificant variations in absorption values and mobile phase ratio with deliberate alterations. In accordance with the validation results, the procedure is simple, specific, precise, accurate, robust and suitable for routine analysis of Tofisopam in bulk and commercial products.