Fully automated analytical method for mycophenolic acid quantification in human plasma using on-line solid phase...

Area of Science:

• Clinical Chemistry
• Pharmacology
• Analytical Chemistry

Background:

• Therapeutic drug monitoring (TDM) is crucial for optimizing immunosuppressive therapy in transplant patients.
• Mycophenolic acid (MPA) is a key immunosuppressant requiring precise quantification for effective TDM.
• Existing MPA quantification methods may lack automation or efficiency.

Purpose of the Study:

• To develop and validate a fully automated method for MPA quantification in plasma.
• To optimize TDM for transplant recipients through improved analytical performance.

Main Methods:

• Automated solid-phase extraction (SPE) using disposable cartridges.
• Reversed-phase high-performance liquid chromatography (RP-HPLC) with diode array detection (DAD).
• Detection of MPA at 306 nm with a retention time of 6.3 minutes.

Main Results:

• Linearity established from 0.2 to 20 microg/mL with a limit of quantification of 0.2 microg/mL.
• Excellent precision (interday/intraday CV < 6%) and accuracy (97.1%–100.8%).
• High extraction efficiency (>90%) and good specificity against co-prescribed drugs.

Conclusions:

• The developed automated method provides a simple, precise, and accurate approach for MPA quantification.
• This method is suitable for routine therapeutic drug monitoring of MPA in transplant patients.
• Enhanced TDM can lead to improved patient outcomes and reduced drug-related toxicity.