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Stepwise binary gradient high-performance liquid chromatographic system for routine drug monitoring
D Hannak1, F Scharbert, R Kattermann
1Institut für Klinische Chemie, Klinikum, Mannheim, Germany.
Journal of Chromatography. A
|March 29, 1996
Summary
This study presents an isocratic high-performance liquid chromatography (HPLC) method for therapeutic drug monitoring (TDM). This method offers faster analysis and improved precision compared to gradient HPLC systems.
Area of Science:
- Analytical Chemistry
- Clinical Chemistry
Background:
- Therapeutic drug monitoring (TDM) optimizes drug efficacy and safety.
- High-performance liquid chromatography (HPLC) is crucial for TDM when immunoassay kits are unavailable.
- The Merck Tox Screening System (MTSS) uses gradient HPLC for substance identification.
Purpose of the Study:
- To adapt the Merck Tox Screening System (MTSS) gradient HPLC method for routine therapeutic drug monitoring (TDM).
- To develop an isocratic HPLC method that offers advantages in analysis time, reproducibility, and precision for TDM.
Main Methods:
- Development of an isocratic HPLC method based on the MTSS gradient system.
- Systematic variation of eluent composition in 10% increments.
- Validation using three example drugs: Amiodarone, Indometacine, and Thiopental.
Main Results:
- The isocratic HPLC method provides shorter analysis times compared to gradient HPLC.
- Improved reproducibility of retention index and precision of results were observed.
- Successful application demonstrated for Amiodarone, Indometacine, and Thiopental.
Conclusions:
- An isocratic HPLC method is suitable and advantageous for routine TDM.
- New substance testing applications can be readily transferred from MTSS gradient runs to the isocratic system.