目的：建立测定血浆中紫杉醇含量的分析方法。方法：采用高效液相色谱法，色谱柱为Phenomenex C18反相色谱柱（250 mm×4.6 mm，5μm )，炔诺酮为内标，流动相为甲醇∶乙腈∶水=40∶30∶30，流速1.0 mL·min-1，检测波长为227 nm，柱温40℃。结果：主峰与杂质峰完全分离，紫杉醇和内标物炔诺酮的保留时间分别为11.4 min和7.8 min。紫杉醇在0.1~100.0μg·mL-1的浓度范围内线性关系良好（r =0.9999）；其低、中、高浓度（0.1、5.0、100.0μg·mL-1）日内精密度的RSD值在2.06%~5.72%，日间精密度的RSD值在2.44%~6.12%，方法回收率在90.76%~97.36%，萃取回收率在92.11%~98.13%。血浆样品在–20℃下放置稳定性和冻融稳定性良好。结论：本方法快速、准确、重现性好，符合生物样品的测定要求，适合作为体内紫杉醇含量的检测方法。%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.
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