Development and full validation of an LC–MS/MS methodology to quantify capmatinib (INC280) following intragastric administration to rats

• DOI: 10.1002/bmc.4768
• Publication Date: 2019-12-10T17:55:19Z
• Authors: Xiaoguang Fan; Guanghu Yang; Wenjuan Cui; Qin Liu; Zhaolong Zhang; Zhikun Zhang
• Keywords: Bioanalysis; Accuracy and precision; Dilution; Matrix (chemical analysis)

Abstract A highly sensitive, specific and simple LC–MS/MS method for quantification of capmatinib (INC280) in rat plasma was presented. The validated terms specificity selectivity, linearity, accuracy precision, matrix effect, extraction recovery, dilution integrity, carryover stability as per the US Food Drug Administration's bioanalytical validation guideline. assay applied from a pharmacokinetic study rats following oral administration at doses 1.0, 3.0 9.0 mg/kg. calibration curve ranges 1 to 2000 ng/ml with desirable linearity r 2 > 0.99. intra‐ inter‐batch accuracies were within 99.24–103.59 97.76–102.83% coefficients variation 5.08–7.36 3.18–4.99%, respectively. No significant interference observed by endogenous peak retention time IS. free any effect showed precise recovery across range, samples stable under all experimental conditions. successfully analyze determine concentration capmatinib. In summary, novel analyzing has been is now being utilized pre‐clinical studies.