Stability Indicating Method Development and Validation of Cenobamate in Bulk and Dosage form by Liquid Chromatography
K. Athulya Damodharan
Department of Pharmaceutical Chemistry, National College of Pharmacy, Manassery, Mukkam Post, Kozhikode, Kerala-673602, India.
. Nuaman
Department of Pharmaceutical Chemistry, National College of Pharmacy, Manassery, Mukkam Post, Kozhikode, Kerala-673602, India.
M. Archana
Department of Pharmaceutical Chemistry, National College of Pharmacy, Manassery, Mukkam Post, Kozhikode, Kerala-673602, India.
Mariya Palathingal
Department of Pharmaceutical Chemistry, National College of Pharmacy, Manassery, Mukkam Post, Kozhikode, Kerala-673602, India.
P. Ashisha
Department of Pharmaceutical Chemistry, National College of Pharmacy, Manassery, Mukkam Post, Kozhikode, Kerala-673602, India.
Akash Marathakam *
Department of Pharmaceutical Chemistry, National College of Pharmacy, Manassery, Mukkam Post, Kozhikode, Kerala-673602, India.
*Author to whom correspondence should be addressed.
Abstract
A simple, Precise, Accurate method was developed for the estimation of Cenobamate by RP-HPLC technique. Chromatographic conditions used are stationary phase symmetry C18 (150 mm* 4.6 mm 5 µm), mobile phase Acetonitrile: 0.01NKH2PO4in the ratio of 55:45 and flow rate was maintained at 1.0ml/min, detection wave length was 272.0 nm; column temperature was set to 30oC. Retention time was found to be 2.908 min. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999.Precision was found to be 0.5 for repeatability and 0.8 for intermediate precision. LOD and LOQ are 0.01µg/ml and 0.03µg/ml respectively. By using above method assay of marketed formulation was carried out 100.32% was present. Degradation studies of Cenobamate were done, in all conditions purity threshold was more than purity angle and within the acceptable range.
Keywords: HPLC, cenobamate, method development, ICH guidelines