Gas chromatography/high-resolution mass spectrometry as a reference method for clomipramine determination

Area of Science:

• Analytical Chemistry
• Pharmacology
• Clinical Chemistry

Background:

• Accurate quantification of plasma clomipramine is crucial for therapeutic drug monitoring.
• Existing methods may lack the required specificity or precision for reliable reference measurements.

Purpose of the Study:

• To develop and validate a novel method for determining plasma clomipramine concentrations.
• To establish a highly specific and accurate reference method for clomipramine analysis.

Main Methods:

• Development of a quantitative method utilizing gas chromatography coupled with high-resolution mass spectrometry (GC/HRMS).
• Validation of the method through assessment of accuracy and precision using spiked plasma samples.

Main Results:

• The GC/HRMS method demonstrated excellent accuracy and precision in plasma sample analysis.
• High specificity was achieved, making the technique suitable for reference purposes.
• Results from the GC/HRMS method showed good agreement with a routine radioimmunoassay (RIA).

Conclusions:

• Gas chromatography/high-resolution mass spectrometry provides a reliable and specific reference method for plasma clomipramine determination.
• This advanced technique offers superior accuracy compared to existing routine methods.
• The developed method can serve as a gold standard for clomipramine quantification in clinical settings.