A new method for quantitative determination of dimemorfan in human plasma using monolithic silica solid-phase...

Area of Science:

• Analytical Chemistry
• Pharmacokinetics
• Biomedical Analysis

Background:

• Accurate quantification of dimemorfan in biological matrices is crucial for pharmacokinetic and clinical studies.
• Existing methods may lack the sensitivity, speed, or simplicity required for routine analysis.

Purpose of the Study:

• To develop and validate a novel, rapid, and simple method for the quantitative determination of dimemorfan in human plasma.
• To assess the method's efficiency, linearity, accuracy, precision, and analyte stability.

Main Methods:

• Solid-phase extraction using C(18) monolithic tips for sample pretreatment.
• Gas chromatography coupled with mass spectrometry (GC-MS) for detection and quantification.
• Validation parameters including linearity, limit of detection, recovery, accuracy, and precision were evaluated.

Main Results:

• High recoveries (≥83%) for dimemorfan and the internal standard were achieved.
• Excellent linearity was observed from 0.25 to 32.0 ng/100 μL plasma, with a low limit of detection (0.125 ng/100 μL).
• The method demonstrated good accuracy (88-105%) and precision (RSD ≤13%), with dimemorfan showing stability under various storage conditions.

Conclusions:

• The developed C(18) monolithic tip extraction method coupled with GC-MS is a robust and efficient technique for dimemorfan quantification in human plasma.
• This method provides a rapid, simple, and reliable approach suitable for routine clinical and research applications.
• The method's performance characteristics support its utility in therapeutic drug monitoring and pharmacokinetic investigations.