DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF ESLICARBAZEPINE IN ESLICARBAZEPINE ACETATE TABLETS
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2013, Vol 4, Issue 5
Abstract
A simple, precise, rapid and accurate stability indicating reverse phase high performance liquid chromatography has been developed and validated for the estimation of Eslicarbazepine Acetate in tablet dosage form. Separation was carried on a Waters e 2695 HPLC system separation module with Empower 2 software, PDA detector waters 2998 and Symmetry-C18 analytical column (5µm; 250x4.6mm), was operated in isocratic mode using mobile phase A consisting of (Phosphate buffer pH 5.0±0.05 and acetonitrile in the ratio of 90:10) and mobile phase B consisting of acetonitrile and water in the ratio of 80:20) is used in the ratio of 65:35 and at a flow rate of 1ml/min with detection wavelength of 215 nm by an injection volume of 20µl and entire separation was carried out at 35°C column temperature. The linearity was found in the range of 5.0-500.0 µg/ml and showed a correlation co-efficient of 0.9999. The retention time of Eslicarbazepine Acetate was found to be 8.0. This study concluded that the proposed method was found to be accurate, reproducible and consistent which is useful for the routine determination of Eslicarbazepine in tablet dosage form. The method is validated as per ICH guidelines by determining its specificity, accuracy, precision, linearity & range, ruggedness, robustness and system suitability.
Authors and Affiliations
Pradeep Singh , Subas Chandra
Keywords
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- EP ID EP130646
- DOI 10.7897/2230-8407.04536
- Views 57
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