Validation of an analytical method using HPLC-MS/MS to quantify osimertinib in human plasma and supplementary stability results.

Validation of an analytical method using HPLC-MS/MS to quantify osimertinib in human plasma and supplementary stability results.
Biomed Chromatogr. 2019 Dec 06;:e4771
Authors: van Veelen A, van Geel R, de Beer Y, Dingemans AM, Stolk L, Ter Heine R, de Vries F, Croes S
Abstract
A new method for quantification of osimertinib (OSIM) in human plasma using a high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) was developed and validated. Methanol was used for protein precipitation and pazopanib (PAZO) as internal standard. Separation was performed on a HyPURITY® C18 analytical column (50 × 2.1 mm; 3 μm) using a gradient elution of ammonium acetate in water and ammonium acetate in methanol, both acidified with formic acid 0.1%. Detection and quantification of OSIM and PAZO was performed by a triple quadruple mass spectrometer with after electrospray ionization. This method led to robust results, as the selectivity, carry-over, precision and accuracy all met pre-specified requirements. OSIM was stable in human serum when stored at -80°C. Reduced stability was found when stored at 2-4°C or room temperature (RT). Degradation of OSIM slowed down in EDTA-plasma and acidified human serum. The limited stability of OSIM at RT should be considered for transport and sample preparation. Plasma samples should be frozen as soon as possible and sample preparation should be performed on dry-ice. In the future, EDTA-plasma an...

Source: Biomedical Chromatography : BMC - December 5, 2019 Category: Biomedical Science Authors: van Veelen A, van Geel R, de Beer Y, Dingemans AM, Stolk L, Ter Heine R, de Vries F, Croes S Tags: Biomed Chromatogr Source Type: research