Development and full validation of an innovative HPLC-diode array detection technique to simultaneously quantify lacosamide, levetiracetam and zonisamide in human plasma

被引:21
作者
Goncalves, Joana [1 ,2 ]
Alves, Gilberto [3 ]
Bicker, Joana [1 ,2 ]
Falcao, Amilcar [1 ,2 ]
Fortuna, Ana [1 ,2 ]
机构
[1] Univ Coimbra, Fac Pharm, Lab Pharmacol, Polo Ciencias Saude, P-3000548 Coimbra, Portugal
[2] Univ Coimbra, CIBIT Coimbra Inst Biomed Imaging & Tanslat Res, Coimbra, Portugal
[3] Univ Beira Interior, CICS UBI Hlth Sci Res Ctr, Av Infante D Henrique, P-6200506 Covilha, Portugal
关键词
PERFORMANCE LIQUID-CHROMATOGRAPHY; TANDEM MASS-SPECTROMETRY; ANTIEPILEPTIC DRUGS; BIOANALYTICAL METHOD; UV METHOD; EPILEPSY; LAMOTRIGINE; SERUM; OXCARBAZEPINE; CARBAMAZEPINE;
D O I
10.4155/bio-2017-0199
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
Aim: To implement pharmacokinetic drug monitoring and individualize the posology of new antiepileptic drugs, the first HPLC-diode array detection method was developed and validated to simultaneously quantify lacosamide, levetiracetam and zonisamide in human plasma. Materials & methods: Preceded by a reproducible liquid-liquid extraction, chromatographic separation was achieved by using a C-18 column of 5 cm length and a mobile phase of water/acetonitrile. Full validation was performed according to in- ternational guidelines. Results: The method was linear within 0.5-30, 2.5-40.0 and 0.5-50.0 mu g ml(-1) for lacosamide, levetiracetam and zonisamide, respectively (r(2) >= 0.998), accurate (-12.411-8.303%), precise (<= 8.875%). Conclusion: This innovative HPLC-diode array detection method was successfully employed in clinical practice and is expected to empower epileptic patients with a personalized pharmacotherapy service. [GRAPHICS] .
引用
收藏
页码:541 / 557
页数:17
相关论文
共 44 条
[1]  
Alexopoulos A., 2013, Epileptology, V1, P38, DOI DOI 10.1016/J.EPILEP.2013.01.001
[2]   Linear regression for calibration lines revisited: weighting schemes for bioanalytical methods [J].
Almeida, AM ;
Castel-Branco, MM ;
Falcao, AC .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2002, 774 (02) :215-222
[3]  
[Anonymous], 2013, Guidance for Industry: Bioanalytical method validation
[4]   The direct cost of epilepsy in the United States: A systematic review of estimates [J].
Begley, Charles E. ;
Durgin, Tracy L. .
EPILEPSIA, 2015, 56 (09) :1376-1387
[5]   Simple and validated HPLC-UV analysis of levetiracetam in deproteinized plasma of patients with epilepsy [J].
Contin, Manuela ;
Mohamed, Susan ;
Albani, Fiorenzo ;
Riva, Roberto ;
Baruzzi, Agostino .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2008, 873 (01) :129-132
[6]   Lacosamide Therapeutic Monitoring in Patients With Epilepsy: Effect of Concomitant Antiepileptic Drugs [J].
Contin, Manuela ;
Albani, Fiorenzo ;
Riva, Roberto ;
Candela, Carmina ;
Mohamed, Susan ;
Baruzzi, Agostino .
THERAPEUTIC DRUG MONITORING, 2013, 35 (06) :849-852
[7]   Simultaneous HPLC-UV analysis of rufinamide, zonisamide, lamotrigine, oxcarbazepine monohydroxy derivative and felbamate in deproteinized plasma of patients with epilepsy [J].
Contin, Manuela ;
Mohamed, Susan ;
Candela, Carmina ;
Albani, Fiorenzo ;
Riva, Roberto ;
Baruzzi, Agostino .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 2010, 878 (3-4) :461-465
[8]  
Cross JH., 2015, BMJ CLIN EVID
[9]   Simultaneous Analysis of 22 Antiepileptic Drugs in Postmortem Blood, Serum and Plasma Using LC-MS-MS with a Focus on Their Role in Forensic Cases [J].
Deeb, Shaza ;
McKeown, Denise A. ;
Torrance, Hazel J. ;
Wylie, Fiona M. ;
Logan, Barry K. ;
Scott, Karen S. .
JOURNAL OF ANALYTICAL TOXICOLOGY, 2014, 38 (08) :485-494
[10]  
European Medicines Agency, 2011, GUIDELINE BIOANALYTI