title: Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets.
abstract: A convenient, simple, accurate, precise and reproducible RP-HPLC method was developed and validated for the estimation of eslicarbazepine acetate in bulk drug and tablet dosage form. Objective was achieved under optimised chromatographic conditions on Dionex RP-HPLC system with Dionex C18 column (250×4.6 mm, 5 μm particle size) using mobile phase composed of methanol and ammonium acetate (0.005 M) in the ratio of 70:30 v/v. The separation was achieved using an isocratic elution method with a flow rate of 1.0 ml/ min at room temperature. The effluent was monitored at 230 nm using diode array detector. The retention time of eslicarbazepine acetate is found to be 4.9 min and the standard calibration plot was linear over a concentration range of 10-90 μg/ml with r(2)=0.9995. The limit of detection and quantification were found to be 3.144 and 9.52 μg/ml, respectively. The amount of eslicarbazepine acetate in bulk and tablet dosage form was found to be 99.19 and 97.88%, respectively. The method was validated statistically using the percent relative standard deviation and the values are found to be within the limits. The recovery studies were performed and the percentage recoveries were found to be 98.33± 0.5%.
authors.affiliation: Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.
authors.forename: M
authors.initials: M
authors.lastname: Singh
authors.affiliation: Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.
authors.forename: L
authors.initials: L
authors.lastname: Kumar
authors.affiliation: Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.
authors.forename: P
authors.initials: P
authors.lastname: Arora
authors.affiliation: Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.
authors.forename: S C
authors.initials: SC
authors.lastname: Mathur
authors.affiliation: Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.
authors.forename: P K
authors.initials: PK
authors.lastname: Saini
authors.affiliation: Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.
authors.forename: R M
authors.initials: RM
authors.lastname: Singh
authors.affiliation: Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.
authors.forename: G N
authors.initials: GN
authors.lastname: Singh
keywords: Eslicarbazepine acetate; ICH guidelines; RP-HPLC; method validation