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目的:建立人血浆中紫杉醇HPLC测定法,为人体内药代动力学研究和药效学评价提供方法学基础。方法:取血浆300μl,以地西泮为内标,采用有机相(叔丁基甲醚)两步提取。常温下氮气吹干,残渣用移动相溶解,进样20μl。色谱条件:ShimPackCLCODS柱;流动相:甲醇乙腈水(25∶40∶39);流速为1.2ml·min-1,检测波长227nm。结果:本法在0.03~5.00mg·L-1间线性良好,相关系数r=0.9999(n=7)。高中低浓度的3个质控样品日间内变异性RSD都在2.31%~4.90%之间,回收率在97.4%~103.3%之间,血浆最低检测浓度为0.008mg·L-1。结论:本方法能简便、准确地测出血浆中微量药物的含量,适于研究需要
OBJECTIVE: To establish a HPLC method for determination of paclitaxel in human plasma, and to provide a methodological basis for pharmacokinetics and pharmacokinetic studies in human. Methods: Take 300μl of plasma and take diazepam as internal standard, and take two steps of organic phase (tert-butyl methyl ether) extraction. Dry at room temperature nitrogen, the residue dissolved with mobile phase, injection 20μl. Chromatographic conditions: Shim PackCLC ODS column; mobile phase: methanol acetonitrile water (25:40:39); flow rate of 1.2ml · min-1, detection wavelength of 227nm. Results: The method was linear in the range of 0.03-5.00 mg · L-1 with a correlation coefficient of 0.9999 (n = 7). The intra-day variability RSDs of three quality control samples with high and low concentrations were between 2.31% and 4.90%, the recoveries were between 97.4% and 103.3%, and the lowest plasma concentrations were 0 .008 mg · L-1. Conclusion: This method can be easily and accurately measure the content of trace drug in plasma, suitable for research needs