Different techniques for the determination of tofisopam

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Spectroscopy

Background:

• Accurate quantification of tofisopam (TF) is crucial for pharmaceutical quality control.
• Development of simple, sensitive, and stability-indicating methods is essential for TF analysis.
• Understanding TF degradation pathways aids in developing robust analytical techniques.

Purpose of the Study:

• To develop and validate five simple and sensitive analytical methods for tofisopam determination.
• To establish stability-indicating methods capable of quantifying TF in the presence of its degradation products.
• To apply the developed methods for TF quantification in pharmaceutical formulations.

Main Methods:

• Spectrophotometric methods including first/second derivative (1D/2D), derivative ratio (1DD), and difference spectrophotometry.
• Thin-layer chromatography (TLC) with densitometric quantification.
• Spectrofluorometry for TF determination via its degradation product.

Main Results:

• All five methods demonstrated linearity within specified concentration ranges.
• Mean recoveries for all methods were excellent, ranging from 98.98% to 100.25%.
• The developed methods were successfully applied to quantify TF in Nodeprine tablets, showing no significant difference from the official method.

Conclusions:

• Five robust and validated analytical methods were successfully developed for tofisopam determination.
• The developed methods are stability-indicating and suitable for TF quantification in pharmaceutical products.
• The study identified a TF degradation product and suggested a degradation pathway under acidic conditions.