Fast and Sensitive HPLC-ESI-MS/MS Method for Etoricoxib Quantification in Human Plasma and Application to...

Area of Science:

• Pharmacokinetics
• Analytical Chemistry
• Bioanalysis

Background:

• Etoricoxib is a widely used non-steroidal anti-inflammatory drug (NSAID).
• Accurate quantification of etoricoxib in biological matrices is crucial for pharmacokinetic and bioequivalence studies.
• Existing analytical methods may lack the sensitivity, speed, or throughput required for large-scale clinical trials.

Purpose of the Study:

• To develop and validate a sensitive, rapid, and high-throughput High-Performance Liquid Chromatography-Electrospray Ionization-Tandem Mass Spectrometry (HPLC-ESI-MS/MS) method.
• To quantify etoricoxib concentrations in human plasma.
• To establish a method suitable for bioequivalence studies.

Main Methods:

• Utilized a one-step methanol protein precipitation technique for sample preparation.
• Employed a tandem mass spectrometer with an electrospray ionization (ESI) source in positive mode.
• Data acquisition was performed using Multiple Reaction Monitoring (MRM) with specific transition ions for etoricoxib and an internal standard (IS).

Main Results:

• The method demonstrated high sensitivity (10.00 ng/mL, S/N > 40) and a wide linear range (10.00–4000.39 ng/mL).
• Validation parameters met European Medicine Agency (EMA) and Food and Drug Administration (FDA) guidelines.
• The assay exhibited selectivity (K prime > 2), a short run time (2 min), negligible matrix effect, and consistent recovery, indicating suitability for high-throughput analysis.

Conclusions:

• The developed HPLC-ESI-MS/MS method is sensitive, selective, rapid, and robust for measuring etoricoxib in human plasma.
• The method's performance was confirmed through application in a bioequivalence study and incurred sample reanalysis.
• This validated assay is well-suited for high-throughput bioanalytical applications, including pharmacokinetic and bioequivalence assessments of etoricoxib formulations.