Stability indicating spectrophotometric methods for determination of bumadizone in the presence of its alkaline degradation product

Objectives

Simple, selective and precise stability indicating spectrophotometric methods were adopted and validated for the quantitative determination of Bumadizone calcium semihydrate (BUM) in presence of its alkaline degradation product (DEG I).

Methods

Method A is based on the application of first derivative (¹D) spectrophotometry, then measuring the amplitude of BUM at 245.4 nm. Method B depends on measuring the peak amplitude of the first derivative of the ratio spectra (¹DD) at 242.6, 260 and 274 nm over a concentration range of 6–20 μg mL⁻¹. Method C is isoabsorptive point spectrophotometry where total concentration of BUM and DEG I was calculated at their isoabsorptive point at 242.2 nm (Aiso) while DEG I concentration alone can be determined at λ_max 320 nm, and then BUM concentration can be determined by subtraction. In Method D ratio subtraction spectrophotometry is applied.

Results

The four methods were found to be specific for determination BUM in presence of different concentrations of DEG I and were successfully applied for the determination of BUM in Octomotol^® tablets.

Conclusion

Statistical comparison between the results obtained by applying the proposed methods and that obtained by the manufacturer one for the determination of the drug was done, and it was found that there is no significant difference between them.