Determination of Sorafenib in Human Plasma by HPLC

OBJECTIVE To develop an HPLC method for the determination of sorafenib in human plasma. METHODS The analytical column was packed with ZORBAX XDB-C₁₈(150 mm×4.6 mm, 5 mm). A mixture of acetonitrile-0.1% trifluoroacetic acid-water(49∶20∶31) was used as the mobile phase with the flow rate of 1.0 mL·min^-1. The detection wavelength was set at 266 nm. The column temperature was set at 35 ℃. The plasma was extracted with ethyl acetate under basic conditions, and itraconazole was used as internal standard. RESULTS Excellent liner relationship was obtained in the range of 0.05-10.00 mg·L^-1(r=0.999 7). The intra-day RSDs were 3.78％, 2.31％and 2.16％, and inter-day RSDs were 4.52％, 3.46％ and 2.14％, respectively at three concentrations(0.1, 2.50, 7.50 mg·L^-1). The method recoveries were (97.2±4.54)%, (100.8±2.51)%, and (100.2±2.17)%, respectively. The absolute recoveries were (80.55±4.13)％, (81.42±2.91)％, (82.07±1.62)%, respectively. CONCLUSION The method is simple, accurate and sutiable for sorafenib cliniacl therapeutic drug monitoring and its pharmacokinetics study.