• RENUKA MUNSHI Department of Clinical Pharmacology, Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai, Maharashtra, India.
  • VISHWAKARMA JV Department of Clinical Pharmacology, Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai, Maharashtra, India.



RP-HPLC, Lacosamide, method development, method validation, human serum


Objective: The main aim of the study was to develop and validate a simple, accurate, and rapid isocratic reverse phase high-performance liquid chromatographic method with UV detection for the determination of lacosamide, an antiepileptic agent, in human serum.

Methods: Chromatographic separation was performed using a reverse phase chromatographic column (Zorbax SB-C18, 5 μm 4.6×250 mm) with a mobile phase being a mixture of potassium dihydrogen phosphate buffer (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile (ratio of 83:17 v/v) at a flow rate of 1.2 mL/min. UV detection was carried out at 210 nm and the sample temperature was maintained at 4°C.

Results: Linear calibration curves in the range of 1.012–40.894 μg/ml gave a correlation coefficient of 0.9988. The intra-day (n=6) and inter-day (n=18) precision (expressed as relative standard deviation) were in the range of 0.79–2.485% and from 0.99 to 3.21%, respectively. The retention time (in minutes) of lacosamide and internal standard was approximately 8.785±0.19 and 3.985±0.77, respectively, with no matrix interference. The method was validated for system suitability, specificity, precision, accuracy, robustness, linearity, limit of detection, and limit of quantification following the International Conference on Harmonization guidelines. The method was further validated using sera of epileptic patients consuming lacosamide, and it was observed that the results matched with the patients’ clinical response.

Conclusion: Our method developed to estimate serum lacosamide level is simple, cost-effective, and reliable for therapeutic drug monitoring.


Download data is not yet available.


Hoy SM. Lacosamide: A review in focal-onset seizures in patients with epilepsy. CNS Drugs 2018;32:473-84. DOI: 10.1007/s40263-018-0523-7, PMID 29785508

Medicine I. Medicine Brands for Generic ’Lacosamide’. Available from: lacosamide [Last accessed on 2022 Jun 10].

Rogawski MA, Tofighy A, White HS, Matagne A, Wolff C. Current understanding of the mechanism of action of the antiepileptic drug lacosamide. Epilepsy Res 2015;110:189-205. doi: 10.1016/j. eplepsyres.2014.11.021, PMID 25616473

Beydoun A, D’Souza J, Hebert D, Doty P. Lacosamide: Pharmacology, mechanisms of action and pooled efficacy and safety data in partial-onset seizures. Expert Rev Neurother 2009;9:33-42. doi: 10.1586/14737175.9.1.33, PMID 19102666

Cawello W. Clinical pharmacokinetic and pharmacodynamic profile of lacosamide. Clin Pharmacokinet 2015;54:901-14. doi: 10.1007/ s40262-015-0276-0, PMID 25957198

Patsalos PN, Spencer EP, Berry DJ. Therapeutic drug monitoring of antiepileptic drugs in epilepsy: A 2018 update. Ther Drug Monit 2018;40:526-48. doi: 10.1097/FTD.0000000000000546, PMID 29957667

Kestelyn C, Lastelle M, Higuet N, Dell’Aiera S, Staelens L, Boulanger P, et al. A simple HPLC-UV method for the determination of lacosamide in human plasma. Bioanalysis 2011;3:2515-22. doi: 10.4155/bio.11.261, PMID 22122600

Jayasimha N, Reddy VK, Sandeep V, Goud ES. Development and validation of RP-HPLC for assay of lacosamide injection. World J Pharm Pharm Sci 2015;4:1067-74.

Devi MS, Varma DP, Rani GT, Srinivas N. Liquid chromatographic assay of lacosamide in human plasma using liquidliquid extraction. Int J Pharm Pharm Sci 2014;6:530-3.

Chakravarthy VK, Shankar DG. HPLC method for determination of lacosamide S(-)Enantiomer in bulk and pharmaceutical formulation. Rasayan J Chem 2011;4:744-52.

Shah S, Vasantharaju SG, Karthik A, Muddukrishna BS. Development and validation of stability-indicating assay method for lacosamide by RP-HPLC. Elixir Int J 2011;38:4174-7.

Raul SK, Mahapatra AK, Kumar BV, Patnaik AK. Stability indicating RP-HPLC method for the estimation of lacosamide in bulk and pharmaceutical dosage form. J Chem Pharm Res 2013;5:732-9.

European Medicines Agency. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures: Text and Methodology. Energy Market Authority of Singapore. Vol. Q2. Amsterdam: European Medicines Agency; 2005. p. R1. Available from: ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_ en.pdf [Last accessed on 2022 Jun 10].

Reimers A, Berg JA, Burns ML, Brodtkorb E, Johannessen SI, Landmark CJ. Reference ranges for antiepileptic drugs revisited: A practical approach to establish national guidelines. Drug Des Dev Ther 2018;12:271-80. doi: 10.2147/DDDT.S154388, PMID 29467570

Harris JA, Murphy JA. Lacosamide and epilepsy. CNS Neurosci Ther 2011;17:678-82. doi: 10.1111/j.1755-5949.2010.00198.x, PMID 20950330

Becerra JL, Ojeda J, Corredera E, Giménez JR. Review of therapeutic options for adjuvant treatment of focal seizures in epilepsy: Focus on lacosamide. CNS Drugs 2011;25 Suppl 1:3-16. doi: 10.2165/1159572- S0-000000000-00000, PMID 22141347



How to Cite

MUNSHI, R., and V. JV. “REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-ULTRAVIOLET-BASED APPROACH FOR METHOD DEVELOPMENT AND VALIDATION OF LACOSAMIDE ESTIMATION IN HUMAN SERUM”. Asian Journal of Pharmaceutical and Clinical Research, vol. 15, no. 11, Nov. 2022, pp. 98-102, doi:10.22159/ajpcr.2022.v15i11.45501.



Original Article(s)