Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

Journal：Biomed Chromatogr

Publication type: Research Article

IF(IF): 1.902

PMID: 30119142 Link To Pubmed Full text Download

A rapid and sensitive method for quantitative analysis by ultra-performance liquid chromatography-tandem mass spectrometry of osimertinib and its metabolite AZ5104 in human plasma was developed and validated. The samples were prepared by protein precipitation and separated on a BEH C18 column (2.1 × 50 mm, 1.7 μm) by gradient elution with 0.1% (v/v) formic acid and 10 mm ammonium acetate in water and acetonitrile as the mobile phase. Electrospray ionization in positive ion mode and multiple reaction monitoring were used to monitor the ion transitions at m/z 500.4 → 385.3 and 486.3 → 371.1. The results indicated that the method had excellent sensitivity and specificity. The validation was performed in a range from 0.5 to 100 ng/mL. Intra-day and inter-day precisions (in terms of RSD) were all <15%, and the accuracies (in terms of RE) were within ±15%. The lower limit of quantification, matrix effect, extraction recovery, stability and dilution integrity were also validated and satisfied the validation criteria.