Abstract

VALIDATION OF STABILITY INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF ASSAY OF CARBAMAZEPINE DRUG IN THE PHARMACEUTICALS TABLET FORMULATIONS USING PHENYTOIN AS AN INTERNAL STANDARD

Shaikh Javed Shaikh Afzal*, Suresh C. Ameta and Pathan Mohd Arif Ali Khan

Abstract

Carbamazepine is an anticonvulsant is used to treat partial seizures, tonic-clonic seizures, pain of neurologic origin such as trigeminal neuralgia, and psychiatric disorders including manic-depressive illness and aggression due to dementia. Validation of stability indicating Simple, Specific, Precise, Accurate, Linear, Rugged, Robust High Performance Liquid Chromatographic method of analysis for determination of assay of Carbamazepine drug in the pharmaceuticals tablet formulations using Phenytoin as an internal standard was performed. The assay was accomplished using a mixture of Methanol, Acetonitrile and Mill-Q water in the volume ratio of 45:20:35v/v/v as mobile phase on Zorbax SB C18, 150 mm x 4.6mm, 5μ as chromatographic column at a flow rate of 1.000 ml per min and a wavelength of 230 nm with a UV detector. The temperature of auto injector and column oven was 100C and 300C receptively. The Injection volume kept as 10 μL. Linearity of the analytical method was evaluated at concentration range of 5.4142 μg/ml to 451.1792 μg/ml with Correlation coefficient (r) value more than 0.999. The LOD and LOQ were 0.3466 μg/mL and 1.0503 μg/mL respectively. The retention time found to be 5.65 min for Carbamazepine and 3.82 min for internal standard respectively. Specificity, Method Precision, System Precision, Ruggedness, Robustness, Recovery, Stability of analytical solution, Filter paper selection study, Stress testing(Force Degradation) at various conditions were performed as per the ICH (Q2) recommendations. All the results were found with in acceptance criteria.

Keywords: Carbamazepine, Phenytoin, High Performance Liquid Chromatographic, Force degradation studies, Assay.