Articles Accepted

NOVEL STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF CLOBAZAM AND RELATED SUBSTANCES FROM THE ORAL SUSPENSION
by Dr. Vrushali, 04 Sep 2020

A novel, sensitive, stability-indicating, gradient, reverse-phase high performance liquid chromatographic method has been developed for quantitative determination of Clobazam and its impurities in oral suspension. The chromatographic separation from degradation products and matrix components was achieved on a YMC Pack ODS-A column with gradient elution of mobile phase containing water and acetonitrile at a flow rate of 1.0 mL /min with the detection at 230 nm. The resolution between Clobazam and all the impurities was greater than 2.0. The drug product was subjected to hydrolytic, oxidative, photolytic and thermal stress conditions as prescribed by International Conference on Harmonization. Clobazam was found to degrade under acid and basic conditions giving rise to impurity E. The method is validated as per the ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.

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