Determination of paclitaxel in human plasma by HPLC

ZHANG Yang; YU Jun-xian

Abstract：Objective:To establish a method for analyzing the concentration of paclitaxel (PTX) in human plasma. Methods:PTX was measured by high performance liquid chromatography (HPLC) with Phenomenex C18column (250 mm × 4.6 mm, 5 μm) at 40℃. Norethisterone was used as the internal standard. The mobile phase was consisted of methanol, acetonitrile and water (40 : 30 : 30), the lfow rate was 1.0 mL·min-1 and the detection wavelength was 227 nm.Results:The peak of impurities and component could be well separated, the retention time of paclitaxel and norethisterone were 11.4 min and 7.8 min, respectively. Excellent linear calibration curve of paclitaxel was obtained within the concentration range of 0.1– 100.0 μg·mL-1 (r = 0.999 9). The intra- and inter-day precision for low, middle and high concentration (0.1, 5.0, 100.0 μg·mL-1) showed that RSD were 2.06%– 5.72% and 2.44%–6.12%, respectively. The recovery of the method was in the range of 90.76%– 97.36%, and the extraction recovery of the method was in the range of 92.11%– 98.13%. Paclitaxel in human plasma was stable after storage at – 20℃ or freeze-thaw for three times. Conclusion:This method is rapid, accurate and reproducible, which is consistent with the requirement for determining biological specimen and suitable for detection of paclitaxel concentration in human plasma.