Determination of Paclitaxel and Docetaxel in Plasma by Crossing Internal Standard Method and its Clinical Application / 中国药师

ABSTRACT

Objective:To establish an HPLC method for the determination of paclitaxel and docetaxel in plasma to provide refer-ence for the individualized treatment regimen and the evaluation of curative effect and adverse reactions. Methods:Paclitaxel and do-cetaxel were used as the internal standard for each other. The samples were precipitated by acetonitrile and separated on a DikMA Dia-monsil C18 column with a mixture of acetonitrile-water (55 45) as the mobile phase. The flow rate was 1. 2 ml·min-1 . The column temperature was set at 25℃. Paclitaxel and docetaxel were detected by UV-detection (λ= 227 nm). Results: A linearity was ob-tained within the range of 0. 078-10. 0 mg·L-1 for paclitaxel and docetaxel. The limit of quantitation was 0. 039 mg·L-1 . The aver-age recovery of paclitaxel and docetaxel was 99. 85% and 100. 35%, respectively. The inter- and intra-day RSD were both less than 5% and the RSD for freeze-thaw stability was below 10%. The plasma concentration of paclitaxel in clinical samples was within the range of 0. 18-6. 16 mg·L-1 and obvious individual difference was shown. Conclusion:Therapeutic drug monitoring is very important due to the obvious differences in plasma concentration of paclitaxel and docetaxel. The established method is sensitive, accurate, con-venient and rapid in r the therapeutic drug monitoring, and is useful for the adverse drug reactions monitoring and pharmacokinetic study.