A simple, efficient and precise stability indicating RP-HPLC method has been developed and validated to measure zonisamide at wavelength (287 nm) in order to assay. Zonisamide is used to treat angina pectoris. Methanol was used as a solvent with λmax of drug was found to be 287 nm. The samples were eluted in an isocratic method using a water symmetry (C18, 5 µm, 4.6 mm × 250 mm) with a mobile phase consisting of pH 2.0 monobasic sodium phosphate: methanol: ACN (50:30:20) using as diluents through ambient temperature delivered at a flow rate 1 ml/min. This sample was used for degradation studies. Linearity was observed in the range of 5-35 μg/ml with a regression coefficient of 0.998. The stress degradation studies showed that zonisamide undergoes degradation in acidic, photo stability and alkaline conditions. Drug was found to be susceptible to acid and alkaline degradation than thermal and photo degradation conditions. The method was quantitatively evaluated in terms of accuracy (recovery), linearity, precision, selectivity and robustness in accordance with standard guidelines. The method is simple and suitable for analyzing zonisamide in bulk and in pharmaceutical formulations.
Loading....