ABSTRACT

A novel, sensitive, stability-indicating gradient RP-HPLC method has been developed for simultaneous estimation of clobazam and its related substances in oral suspension. The chromatographic separation of degradation products and matrix components was executed on a YMC Pack ODS-A column with gradient mode. The mobile phase composed of water and acetonitrile and flow rate was 1.0 mL min-1, while 230 nm was wavelength of detection. The resolution greater than 2.0 between clobazam and the impurities was achieved. The forced degradation study was carried out as per ICH guidelines. The drug product was exposed to hydrolysis, oxidation, photolysis and thermal conditions to achieve degradant formation. Clobazam was degraded under acidic and basic hydrolytic conditions that produced impurity E. The specificity, linearity, limit of detection/quantification, accuracy, precision and robustness was validated as per ICH guidelines.