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Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets.
Indian J Pharm Sci. 2013 Nov; 75(6):736-9.IJ

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+Show Affiliations

Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.Analytical Research and Development Division, Indian Pharmacopoeia Commission, Government of India, Ministry of Health and Family Welfare, Ghaziabad-201 002, India.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

24591752

Citation

Singh, M, et al. "Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets." Indian Journal of Pharmaceutical Sciences, vol. 75, no. 6, 2013, pp. 736-9.
Singh M, Kumar L, Arora P, et al. Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets. Indian J Pharm Sci. 2013;75(6):736-9.
Singh, M., Kumar, L., Arora, P., Mathur, S. C., Saini, P. K., Singh, R. M., & Singh, G. N. (2013). Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets. Indian Journal of Pharmaceutical Sciences, 75(6), 736-9.
Singh M, et al. Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets. Indian J Pharm Sci. 2013;75(6):736-9. PubMed PMID: 24591752.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and Validation of an RP-HPLC Method for Quantitative Estimation of Eslicarbazepine Acetate in Bulk Drug and Tablets. AU - Singh,M, AU - Kumar,L, AU - Arora,P, AU - Mathur,S C, AU - Saini,P K, AU - Singh,R M, AU - Singh,G N, PY - 2013/05/02/received PY - 2013/10/24/revised PY - 2013/10/29/accepted PY - 2014/3/5/entrez PY - 2014/3/5/pubmed PY - 2014/3/5/medline KW - Eslicarbazepine acetate KW - ICH guidelines KW - RP-HPLC KW - method validation SP - 736 EP - 9 JF - Indian journal of pharmaceutical sciences JO - Indian J Pharm Sci VL - 75 IS - 6 N2 - 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%. SN - 0250-474X UR - https://www.unboundmedicine.com/medline/citation/24591752/Development_and_Validation_of_an_RP_HPLC_Method_for_Quantitative_Estimation_of_Eslicarbazepine_Acetate_in_Bulk_Drug_and_Tablets_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24591752/ DB - PRIME DP - Unbound Medicine ER -
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