G. Raveendra Babu, M. Sowjanya, M. Rama Ayyappa, A. Ravi Kumar, C. Anusha, A. Priyanka, T. Eswari Bhavani, G. Krishna Sindu, K. Raja Shekar, D. Ramesh
G. Raveendra Babu1*, M. Sowjanya3, M. Rama Ayyappa1, A. Ravi Kumar2, C. Anusha1, A. Priyanka1, T. Eswari Bhavani1, G. Krishna Sindu1, K. Raja Shekar1, D. Ramesh1
1Department of Pharmaceutical Analysis, Alluri Krishna Rao and Govindamma College of Pharmacy, Nallajerla - 534112, Andhra Pradesh, India.
2Department of Pharmacognosy, Alluri Krishna Rao and Govindamma College of Pharmacy, Nallajerla - 534112, Andhra Pradesh, India.
3Department of Chemistry, Vijaya Teja Degree College, Andanki - 523201, Andhra Pradesh, India.
Volume - 14,
Issue - 3,
Year - 2021
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 30oC 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.
Cite this article:
G. Raveendra Babu, M. Sowjanya, M. Rama Ayyappa, A. Ravi Kumar, C. Anusha, A. Priyanka, T. Eswari Bhavani, G. Krishna Sindu, K. Raja Shekar, D. Ramesh. A Novel Stability-indicating RP-UPLC Method for the Determination of Cenobamate in Bulk and Pharmaceutical Dosage Forms. Research J. Pharm. and Tech 2021; 14(3):1221-1225. doi: 10.5958/0974-360X.2021.00217.1
1. Nakramura M, Cho JH, Jang IS. Effects of Cenobamate, a newly developed anti-epileptic drug, on voltage-gated sodium channels in rat hippocampal CA3 neurons. Eur J Pharmacol. 2019; 15 (855): 175-182.
2. Kasteleijn NT, Diventure BD, Pollard JR, Mizne S, French JA. Suppression of the photoparoxysmal response in photosensitive epilepsy with Cenobamate. Neurology. 2019; 93(6): e559-e567.
3. FDA Approved Drug Products: Xcopri Cenobamate Oral Tablets.
4. Lavanya G, Sunil M, Eswarudu MM, Eswaraiah CM, Harisudha K, Spandana NB. Analytical method validation: an updated review. IJPSR. 2013; 4(4): 1280-1286.
5. Geneva: IFPMA; 1997. International Conference on Harmonization. Validation of Analytical Procedures: Methodology Q2B, International Conference on Harmonization 1197.