摘要
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。
OBJECTIVE:To establish a HPLC assay for the determination of paclitaxel in human plansma.METHOD: With diazepam as the internal standard, a two step extraction was performed with tert butyl methyl ether.The oragnic layer was evaporated and the residual was reconstituted with mobile phase.The concentration of paclitaxel and IS were assayed on a C 18 column with a mobile phase consisting of methanol acetonnitrile water(25∶40∶39)at a flow rate of 1.2ml·min -1 and detected at 227nm.RESULTS:A linearity was obstained from 0.03 to 5.00 mg·L -1 of paclitaxel in plasma with a good correlation ( r =0.9999, n =7).The intra-day and interday validations were less than 4.90%,and the mean recoveries were 98.24%,103.34% and 97.42%for low ,middle and high check samples,respectively(0.25,2.50,4.00 mg·l -1 ).CONCLUSION:The improved method was a sensitive,reproducible and simple assay.It is suitable for clinical pharmacokinetic study.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
1999年第1期41-43,共3页
Chinese Pharmaceutical Journal
