A stability indicating HPLC method for the determination of clobazam and its basic degradation product characterization

BACKGROUND: Clobazam is used for the treatment of different types of seizure and epilepsy. The present research is undertaken to study the systematic forced degradation of clobazam and to identify its main degradation product under basic conditions. METHODS: The degradation of clobazam was studied under different conditions. Clobazam and its degradation products were separated using a Nova-Pak C18 column and a mixture of KH(2)PO(4) 50 mM (pH 8.5) and acetonitrile (50:50, v/v) as the mobile phase with UV detection at 230 nm. RESULTS: The within-day and between-day precision values in the calibration range of 0.1-20 μg/ml were within 0.5-1.5%. Clobazam was relatively stable in solid from under exposure to visible and UV light and also heat. The clobazam aqueous solution of clobazam was more labile under exposure to visible and UV light. The bulk drug was significantly degraded under exposure to 2 M HCl, 0.1 M NaOH or 3% H(2)O(2). Using the tablet powder, higher degradation rates were observed under different stress conditions. The main degradation product of clobazam under basic condition was subsequently characterized. CONCLUSION: The developed method could be used for the determination of clobazam in the presence of its degradation products with acceptable precision and accuracy. The applicability of the proposed method was evaluated in commercial dosage forms analysis.