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

Development and full validation of an LC-MS/MS methodology to quantify capmatinib (INC280) following intragastric administration to rats. Biomed Chromatogr. 2019 Dec 10;:e4768 Authors: Fan X, Yang G, Cui W, Liu Q, Zhang Z, Zhang Z Abstract A highly sensitive, specific and simple LC-MS/MS method for quantification of capmatinib (INC280) in rat plasma was presented. The LC-MS/MS method was validated in terms of specificity and selectivity, linearity, accuracy and precision, matrix effect, extraction recovery, dilution integrity, carryover and stability as per USFDA's bioanalytical method validation guideline. The validated assay was applied for quantification of capmatinib from pharmacokinetic study in rats following oral administration at the doses of 1.0, 3.0, and 9.0 mg/kg. The calibration curve ranges from 1 ng/mL to 2000 ng/mL with desirable linearity and r2 > 0.99. The intra-batch and inter-batch accuracy were within 99.24-103.59% and 97.76-102.83% with coefficient of variation 5.08-7.36% and 3.18-4.99%, respectively. No significant interference observed by endogenous peak at the retention time of capmatinib and IS. The assay was free from any matrix effect, precise recovery across the calibration curve range and samples were stable under all experimental conditions. The validated assay was successfully applied to analyze plasma samples of pharmacokinetic study in rat to determine concentration of capmatinib. In summary, a...
Source: Biomedical Chromatography : BMC - Category: Biomedical Science Authors: Tags: Biomed Chromatogr Source Type: research