Quality by design-based approach for the development of an analytical method for quantifying ponatinib in rat plasma.

ABSTRACT: Ponatinib is a potent tyrosine kinase inhibitor that is approved for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. To further expand its clinical applications, accurate quantification of ponatinib in plasma is essential. In this study, we developed and validated a sensitive and selective high-performance liquid chromatography (HPLC) method coupled with a fluorescence detector (FLD) to measure ponatinib concentrations in rat plasma using the Analytical Quality by Design approach. Briefly, we screened and optimized the critical method parameters using the Taguchi and Box-Behnken designs. The developed method had excellent linearity in the range of 1-1000 ng/mL, sensitivity, and reproducibility, and required minimal sample volume

SUBMITTER: Koo N 

PROVIDER: S-EPMC11471595 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature