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DOI: 10.1055/s-0032-1301911
Development of a Sensitive Bioanalytical Method for the Quantification of Lacosamide in Rat Plasma. Application to Preclinical Pharmacokinetics Studies in Rats
Publikationsverlauf
received 22. September 2011
accepted 03. Januar 2012
Publikationsdatum:
01. März 2012 (online)

Abstract
A sensitive and selective high performance liquid chromatographic (HPLC) method was developed and validated for quantification of lacosamide in rat plasma. A liquid-liquid extraction procedure was optimized to extract lacosamide from rat plasma. Chromatographic separation was accomplished using a reversed phase C18 Hichrom (250×4.6 mm, 5 µm) column with the mobile phase consisting of acetonitrile-phosphate buffer (pH 3.2±0.1; 20 mM) (21:79, v/v) at a flow rate of 1 mL/min. Both intra- and inter day assay precision and accuracy were lower than 15% CV. The lower limit of quantitation was 25 ng/mL for lacosamide and the response was linear in a concentration range from 25 to 10 000 ng/mL. The developed method was successfully used for the preclinical pharmacokinetic study of lacosamide in rats.
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References
- 1 European Medicines Agency. Assesssment report for Vimpat. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000863/WC500050341.pdf 2008 Accessed August 10 2010
- 2 Perucca E, Yasothan U, Clincke G et al. Lacosamide. Nat Rev Drug Discov 2008; 7: 973-974
- 3 Ratnaraj N, Greenaway C, Sander JW et al. A high-performance liquid chromatography assay to monitor the new antiepileptic drug lacosamide in patients with epilepsy. Ther Drug Monit 2010; 32: 448-452
- 4 U.S Food and Drug Administration Center for Drug Evaluation and Research, Guidance for Industry. Bioanalytical Method Validation, May 2001. Available from http:/www.fda.gov/cder/guidance/4252fnl.pdf Cited on 05/06/08