AccScience Publishing / GTM / Volume 2 / Issue 3 / DOI: 10.36922/gtm.1265
Cite this article
150
Download
1150
Views
Journal Browser
Volume | Year
Issue
Search
News and Announcements
View All
ORIGINAL RESEARCH ARTICLE

A simple, fast, and cost-effective high-performance liquid chromatography-ultraviolet validated method to quantify lacosamide in therapeutic drug monitoring

Ángeles Gloria Rodríguez-Basso1 María Cecilia Kravetz2* María Sylvia Viola1 Florencia Ayelén Fernández2 Nicolás Martín Barrionuevo2 Damián Consalvo3 Mariano Núñez2 Guillermo Federico Bramuglia1,4
Show Less
1 Department of Pharmacology, Faculty of Pharmacy and Biochemistry, University of Buenos Aires, Buenos Aires, Argentina
2 Institute of Pharmacology, Faculty of Medicine, University of Buenos Aires, Buenos Aires, Argentina
3 Institute of Neurology and Neurosurgery, Sanatorio de Los Arcos, Buenos Aires, Argentina
4 Fundación Investigar, Buenos Aires, Argentina
Global Translational Medicine 2023, 2(3), 1265 https://doi.org/10.36922/gtm.1265
Submitted: 7 July 2023 | Accepted: 5 September 2023 | Published: 26 September 2023
© 2023 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
Abstract

Lacosamide is a third-generation anticonvulsant used in the treatment of epilepsy. While therapeutic levels for various patient subpopulations are still under investigation to achieve optimal responses, therapeutic drug monitoring has been proven to be useful in improving patient management. To ensure the reliability of results, it is essential to establish a reliable quantitative method. Thus, the aim of this study was to develop and validate a simple and feasible method for quantifying lacosamide in human plasma, with the specific aim of facilitating drug monitoring purposes. A high-performance liquid chromatography method with ultraviolet detection was developed for the quantification of lacosamide in human plasma. Analyte recovery was achieved through ethyl acetate extraction, with propranolol serving as the internal standard. A C18 column and a mobile phase consisting of 10 mM phosphate buffer and acetonitrile (70:30 v/v, pH = 3.5) were employed. Validation parameters included specificity, linearity, repeatability, precision, accuracy, sensitivity, and stability. The method exhibited linearity within the range of 2.5 – 30 μg/ml (R2 = 0.997), with a limit of quantitation of 2.29 μg/ml. The average recovery percentage was 100.2%, and it proved to be accurate, precise, and specific. In plasma samples, the drug content remained stable for 72 h at 4°C, 1 month at −20°C, and 2 years at −80°C. The post-processed sample remained stable for 1 week under all tested conditions. Due to its simplicity, short analysis time, sensitivity, and cost-effectiveness, the proposed analytical method proves to be useful for therapeutic monitoring and pharmacokinetic studies of lacosamide.

Keywords
High-performance liquid chromatography
Lacosamide
Pharmacokinetics
Funding
University of Buenos Aires
Conflict of interest
The authors declare they have no competing interests.
References
  1. Beydoun A, D’Souza J, Hebert D, et al., 2009, Lacosamide: Pharmacology, mechanisms of action and pooled efficacy and safety data in partial-onset seizures. Expert Rev Neurother, 9: 33–42. https://doi.org/10.1586/14737175.9.1.33

 

  1. EMA European Medicines Agency, 2022, Vimpat Product Monograph, Available from: https://www.ema.europa.eu/en/ medicines/human/EPAR/vimpat [Last accessed on 2023 Jan 09].

 

  1. Kawasaki Y, Sendo T, 2016, Monitoring of the blood concentrations of antiepileptic drugs (TDM). Rinsho Byori, 64: 1373–1380. https://doi.org/10.1002/ana.25641

 

  1. Aícua-Rapún I, André P, Rossetti AO, et al., 2020, Therapeutic drug monitoring of newer antiepileptic drugs: A randomized trial for dosage adjustment. Ann Neurol, 87: 22–29. https://doi.org/10.1002/ana.25641

 

  1. Landmark CJ, Johannessen SI, Patsalos PN, 2020, Therapeutic drug monitoring of antiepileptic drugs: Current status and future prospects. Expert Opin Drug Metab Toxicol, 16: 227–238. https://doi.org/10.1080/17425255.2020.1724956

 

  1. Czornyj L, Guido PC, Bramuglia G, et al., 2018, High incidence of persistent subtherapeutic levels of the most common AEDs in children with epilepsy receiving polytherapy. Epilepsy Res, 148: 107–114. https://doi.org/10.1016/j.eplepsyres.2018.09.008

 

  1. Kumar B, Modi M, Saikia B, et al., 2017, Evaluation of brain pharmacokinetic and neuropharmacodynamic attributes of an antiepileptic drug, lacosamide, in hepatic and renal impairment: Preclinical evidence. ACS Chem Neurosci, 8: 1589–1597. https://doi.org/10.1021/acschemneuro.7b00084

 

  1. Cawello W, Boekens H, Bonn R, 2012, Absorption, disposition, metabolic fate and elimination of the anti-epileptic drug lacosamide in humans: Mass balance following intravenous and oral administration. Eur J Drug Metab Pharmacokinet, 37: 241–248. https://doi.org/10.1007/s13318-012-0093-x

 

  1. Schultz L, Mahmoud SH, 2020, Is therapeutic drug monitoring of lacosamide needed in patients with seizures and epilepsy? Eur J Drug Metab Pharmacokinet, 45: 315–349. https://doi.org/10.1007/s13318-019-00601-8

 

  1. Greenaway C, Ratnaraj N, Sander JW, et al., 2010, A high-performance liquid chromatography assay to monitor the new antiepileptic drug lacosamide in patients with epilepsy. Ther Drug Monit, 32: 448–452. https://doi.org/10.1097/FTD.0b013e3181dcc5fb

 

  1. Valarmathi R, Banu SF, Akilandeswari S, 2013, A review on new antiepileptic drug-lacosamide and its analytical methods. Int J Pham Chem Sci, 2: 181–186.

 

  1. Nazma S, Yasaswini M, Sai Supraja M, et al., 2015, Development and validation of RP-HPLC method for the estimation of lacosamide in bulk and parenteral dosage form. Int J Res Pharm Chem, 5: 355–360.

 

  1. Sreenivasulu V, Rao DR, Maheswar U, et al., 2011, Development and validation of a stability-indicating RP-HPLC method for determination of lacosamide. Res J Pharm Biol Chem Sci, 2: 1–11.

 

  1. United State Pharmacopeia, 2022, National Formulary 38 (USP 43/2019 NF 38)-General Chapter 621 Chromatography. Available from: https://www.usp.org/sites/default/files/usp/ document/harmonization/gen-chapter/harmonization-november-2021-m99380.pdf [Last accessed on 2023 Jan 21].

 

  1. USA Food and Drug Administration (FDA), 2018, Guidance for Industry Bioanalytical Method Validation. Available from: https://www.fda.gov/files/drugs/published/ Bioanalytical-Method-Validation-Guidance-for-Industry. pdf [Last accessed on 2022 Jan 03].

 

  1. International Conference on Harmonization: ICH Harmonized Tripartite Guideline, 2021, Q2 (R1) Validation of Analytical Procedures: Text and Metodology, Guidance for Industry. Available from: https://www. fda.gov/regulatory-information/search-fda-guidance-documents/q2r1-validation-analytical-procedures-text-and-methodology-guidance-industry [Last accessed on 2022 Sep 12].

 

  1. Argentina ANMAT, 2013, Disposición 4394/2013 Buenas Prácticas de Laboratorio. https://www.argentina.gob.ar/ normativa/nacional/disposici%C3%B3n-4394-2013-217492 [Last accessed on 2022 Sep 12].

 

  1. R Core Team, 2018, R: A Language and Environment for Statistical Computing, R Foundation for Statistical Computing, Vienna, Austria. Available from: https:// www.R-project.org/ [Last accessed on 2023 Mar 15].

 

  1. Caballero RR, González RA, Lavaut JA, 1998, Propranolol y sus ésteres: Detección y resolución enantiomérica (Propranolol and its esters: detection and enantiomeric resolution). Rev Cuba Farm, 32: 130–139. (Article in Spanish)

 

  1. Dong MH, 2019, HPLC and UHPLC for Practicing Scientists. 2nd ed. Hoboken NY: John Wiley and Sons, Inc.

 

  1. Gonçalves J, Alves G, Bicker J, et al., 2018, Development and full validation of an innovative HPLC-diode array detection technique to simultaneously quantify lacosamide, levetiracetam and zonisamide in human plasma. Bioanalysis, 10: 541–557. https://doi.org/10.4155/bio-2017-0199

 

  1. Kestelyn C, Lastelle M, Higuet N, et al., 2011, A simple HPLC-UV method for the determination of lacosamide in human plasma. Bioanalysis, 3: 2515–2522. https://doi.org/10.4155/bio.11.261

 

  1. Lipecki Y, Haen E, 2022, Simultaneous quantification of 11 antiseizure medications and metabolites in serum for therapeutic drug monitoring using high-performance liquid chromatography with ultraviolet detection: A short communication. Ther Drug Monit, 44: 345–350. https://doi.org/10.1097/FTD.0000000000000908

 

  1. Carona A, Bicker J, Silva R, et al., 2021, HPLC method for the determination of antiepileptic drugs in human saliva and its application in therapeutic drug monitoring. J Pharm Biomed Anal, 197: 113961. https://doi.org/10.1016/j.jpba.2021.113961

 

  1. Mohamed FA, Ali MF, Rageh AH, et al., 2019, Highly sensitive UHPLC-DAD method for simultaneous determination of two synergistically acting antiepileptic drugs; levetiracetam and lacosamide: Application to pharmaceutical tablets and human urine. Biomed Chromatogr, 33: e4554. https://doi.org/10.1002/bmc.4554
Share
Back to top
Global Translational Medicine, Electronic ISSN: 2811-0021 Published by AccScience Publishing