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Control serum for therapeutic drug monitoring
P Schneiderka1, M Hostlovská, L Loub
1Department of Clinical Biochemistry, Charles University, Praha, Czech Republic.
Insights
A new control serum, EXAPHARM, for therapeutic drug monitoring (TDM) shows excellent stability and homogeneity. It is suitable for high-performance liquid chromatography (HPLC) analysis of antiepileptic and cardiac drugs.
Area of Science:
- Clinical Chemistry
- Pharmacology
- Analytical Chemistry
Background:
- Therapeutic Drug Monitoring (TDM) is crucial for optimizing patient drug dosages.
- Accurate control materials are essential for reliable TDM results.
- EXAPHARM is a novel control serum designed for TDM applications.
Purpose of the Study:
- To evaluate the suitability of the new EXAPHARM control material for TDM.
- To assess the stability and homogeneity of EXAPHARM.
- To determine potential interferences of EXAPHARM in HPLC analysis.
Main Methods:
- Evaluation of EXAPHARM AED (6 antiepileptic drugs) and EXAPHARM CARD (4 cardiac/antiasthmatic drugs).
- Assessment of inter-bottle homogeneity and material stability.
- High-performance liquid chromatography (HPLC) analysis to detect interferences.
Main Results:
- EXAPHARM demonstrated outstanding stability and inter-bottle homogeneity.
- No interferences were observed during HPLC analysis under the described conditions.
- The horse serum matrix, while different from human serum, did not impede analytical accuracy.
Conclusions:
- EXAPHARM is a highly suitable control serum for TDM.
- The material is reliable for use with HPLC methods.
- EXAPHARM provides a stable and homogeneous standard for drug concentration measurements.
Abstract:
New control material EXAPHARM (IMUNA s.p., Sarisské Michalany, Slovakia) for therapeutic drug monitoring (TDM) was evaluated. It is produced in two types: Exapharm AED containing 6 antiepileptic drugs and Exapharm CARD with 4 cardiac and antiasthmatic drugs. Both contain horse serum as a matrix, which is different in some parameters from human serum. Our results approved an outstanding stability and inter-bottle homogeneity of the material. Evidence was presented that no interferences occur in high performance liquid chromatography (HPLC) under the conditions described. It is concluded, that this control serum is very suitable for TDM by HPLC.