Abstract
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 KH2PO4
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% H2O2
. 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.
Keywords: Clobazam, HPLC, Stability indicating, Stress degradation