Simple Determination of Plasma Ponatinib Concentration Using HPLC

Area of Science:

• Pharmacology
• Analytical Chemistry
• Clinical Diagnostics

Background:

• Ponatinib is a crucial tyrosine kinase inhibitor for treating specific leukemias.
• Accurate monitoring of plasma ponatinib concentrations is essential for effective patient treatment.
• Existing methods for ponatinib quantification may lack simplicity or routine applicability.

Purpose of the Study:

• To develop and validate a straightforward method for determining plasma ponatinib concentration.
• To assess the utility of this method for therapeutic drug monitoring in clinical settings.

Main Methods:

• Plasma samples were extracted using an Oasis HLB cartridge.
• High-performance liquid chromatography (HPLC) with UV detection was employed for separation and quantification.
• Bosutinib served as the internal standard for the assay.

Main Results:

• The developed HPLC method demonstrated linearity over a concentration range of 5-250 ng/mL (r²=0.9999).
• Intra-day and inter-day validation showed coefficients of 2.1-6.0% and 4.5-8.0%, respectively.
• The method achieved high accuracy (-1.5-9.0%) and recovery (>86%), with patient plasma concentrations measured at 43.6 and 49.3 ng/mL post-administration.

Conclusions:

• The developed HPLC-UV method is simple, accurate, and reliable for quantifying plasma ponatinib.
• This assay is suitable for routine therapeutic drug monitoring in hospital laboratories.
• The method supports optimizing ponatinib dosage for patients with chronic myeloid leukemia and related conditions.