Multi-analyte assay of 23 Anti Epileptic Drugs (AEDs) in human plasma Renata Lagewaard, Ronald Vermunt, Toos de Mooy, Jos vd Elshout, Robert vd Wegen, Robert Wortelboer and Rudi Segers Introduction Until the early 1990s, the choice of antiepileptic medication was limited to traditional drugs such as phenobarbital, primidone, phenytoin, carbamazepine and valproate. Although these drugs have the advantage of proven efficacy, many patients are left with refractory (break-through) seizures. Since then, many new medications have been approved, expanding treatment options. The newer AEDs offer advantages that include one or more of the following: fewer drug interactions and side effects, better tolerance, unique mechanisms of action, and/or a broader spectrum of activity. When monotherapy fails, combination therapy is tried in an attempt to improve efficacy, tolerability, or both. There continues to be a need for reliable assays of most of the compounds mentioned. In order to support clinical development with pharmacokinetics, and for therapeutic drug monitoring purposes, Eurofins Medinet has developed and validated 5 methods for a combined, fast and reliable analysis of 23 AEDs. Method 1 Narrow-spectrum AEDs: Broad-spectrum AEDs: Analytical conditions Number of Extraction procedure Instrument Analytical column Detection Analytes Method 2 Results Method 1 Method 3 Analyte Range (mg/L) Intra-day precision (CV%) Inter-day precision (CV%) Accuracy (%) Method 2 Analyte Range (mg/L) Intra-day precision (CV%) Inter-day precision (CV%) Accuracy (%) Method 4 Method 3 Analyte Range (mg/L) Intra-day precision (CV%) Inter-day precision (CV%) Accuracy (%) Method 5 Method 4 Analyte Range (mg/L) Intra-day precision (CV%) Inter-day precision (CV%) Accuracy (%) Method 5 Analyte Range (mg/L) Intra-day precision (CV%) Inter-day precision (CV%) Accuracy (%) Conclusion References
A set of HPLC and LC/MS methods for the combined determination of 23 Anti Epileptic Drugs was successfully validated according to the
1- Eurofins Medinet validation study 4032041003
FDA guidance for industry. These methods have adequate specificity, selectivity, precision and accuracy. There were no significant matrix
effects, and the long-term stability of the frozen biological samples was demonstrated. On top of the 20 compounds listed, 3 additional
2- Eurofins Medinet validation study 4032041101
proprietory new chemical entities were included in the methods. Details for those compounds cannot be disclosed. The methods have been
used to support pharmacokinetic studies, and also for therapeutic drug monitoring purposes.
3- Eurofins Medinet validation study 40320412024- Eurofins Medinet validation study 41270608015- Eurofins Medinet validation study 4127090809
Eurofins Medinet Breda, the Netherlands
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Multi-analyte assay of 23 Anti Epileptic Drugs