Validation of a liquid chromatography assay for the quantification of the Raf kinase inhibitor BAY 43-9006 in small volumes of mouse serum.
BAY 43-9006 is a selective Raf-1 kinase inhibitor with antitumor activity against a variety of human cancers. A highly sensitive HPLC method for determination of BAY 43-9006 in small volumes of serum (30 microl) was developed. Sample preparation involved a liquid-liquid extraction procedure with tolnaftate as internal standard followed by linear gradient elution at a reversed phase C18 column and UV detection. The method was selective and the calibration curves were linear over the concentration range of 80-2000 ng/ml. The intra-day accuracy ranged from 99.9 to 107.6% and the inter-day accuracy from 94.6 to 115%. The lower limit of quantitation (LOQ) was 80 ng/ml with an accuracy of 105.8%. Thus, this method has been validated and can be applied for the drug monitoring or pharmacokinetic studies of BAY 43-9006 in small volumes of serum samples.
Institut für Pharmazie und Lebensmittelchemie, Bayerische Julius-Maximilians-Universität, Am Hubland, 97074 Würzburg, Germany.
Samar
S
Afify
Ulf R
UR
Rapp
Petra
P
Högger
D000818:Animals; D001557:Benzenesulfonates / Q000097:blood*; D002138:Calibration; D004791:Enzyme Inhibitors / Q000097:blood*; D051379:Mice; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D019908:Proto-Oncogene Proteins c-raf / Q000037:antagonists & inhibitors*; D011725:Pyridines / Q000097:blood*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D000077157:Sorafenib
D001557:Benzenesulfonates; D004791:Enzyme Inhibitors; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib; D019908:Proto-Oncogene Proteins c-raf