Development and validation of a high-performance liquid chromatography ultraviolet method for lapatinib...

Area of Science:

• Analytical Chemistry
• Pharmacology
• Clinical Chemistry

Background:

• Lapatinib is a critical tyrosine kinase inhibitor used in cancer therapy.
• Accurate quantification of lapatinib in biological matrices is essential for effective treatment and monitoring.
• Existing methods may lack the required selectivity, precision, or throughput for routine clinical use.

Purpose of the Study:

• To develop and validate a selective and precise high-performance liquid chromatography (HPLC) ultraviolet (UV) method for lapatinib determination in human plasma.
• To establish a reliable analytical technique for quantifying lapatinib concentrations in patient samples.
• To assess the utility of the developed method for therapeutic drug monitoring (TDM) in clinical practice.

Main Methods:

• Development and validation of an HPLC-UV method utilizing isocratic elution on a C18 Ultrabase column.
• Protein precipitation of plasma samples using acetonitrile, followed by separation with a mobile phase of acetonitrile/20 mM ammonium acetate (53:47, v/v).
• Quantification at 260 nm, with analysis of linearity, precision (inter- and intraday CV < 7%), detection limits (LOD 0.1 µg/mL, LOQ 0.2 µg/mL), and recovery (>86.7%).

Main Results:

• The developed HPLC-UV method demonstrated high selectivity and precision for lapatinib quantification in human plasma.
• Linearity was established over the concentration range of 0.2-10 µg/mL, with excellent inter- and intraday precision.
• The assay achieved low limits of detection and quantification, with high recovery rates, indicating robustness.

Conclusions:

• A validated, selective, and precise HPLC-UV method for lapatinib determination in human plasma has been successfully developed.
• The assay is suitable for quantifying lapatinib in patient plasma, supporting therapeutic drug monitoring.
• This method can be valuable for optimizing lapatinib dosage and improving treatment outcomes in cancer patients.