A novel stability-indicating RP-UPLC method for the determination of cenobamate in Bulk and Pharmaceutical dosage forms

The objective of the study was to develop a novel stability-indicating RP-UPLC method for the determination of Cenobamate in bulk and pharmaceutical dosage form. The chromatographic separation was achieved with Acquity BEH C₁₈ (50mm x 4.6mm, 2.7μ) column thermostated at 30°C with mobile phases containing water: acetonitrile in the ratio of (50: 50, v/v). The flow rate was maintained at 0.3ml/min and injection volume was found to be 0.30μl. The detection was done at 271.0nm using TUV detector. The retention time was found to be 1.012min of Cenobamate. Linearity study was carried out between 12.5 to 75μg/ml concentration levels and R² value was found to be as 0.999. The %RSD of intra-day precision and inter-day precision was found to be 0.6% and 0.3%, respectively. The LOD and LOQ were found to be 0.05μg/ml and 0.16μg/ml, respectively. Stability-indicating studies were carried out under various stress conditions to demonstrate the stability-indicating capability of the developed RP-UPLC method. The proposed method was found to be simple, precise, and accurate and validated according to the International Conference on Harmonization guidelines.