高效液相色谱法测定紫杉醇亚微乳含量  

Content Determination of Paclitaxel Submicroemulsion by HPLC

作　　者：夏学军[1] 王艳宝[1] 徐佳茗 张鹏霄[1] 金笃嘉[1] 刘玉玲[1] 

机构地区：[1]中国医学科学院北京协和医学院药物研究所.药物传输技术及新型制剂北京市重点实验室,北京100050

出　　处：《中国药业》2014年第3期26-27,共2页China Pharmaceuticals

基　　金：北京市2011年阶梯计划项目;项目编号:Z111102055311078

摘　　要：目的建立测定紫杉醇亚微乳含量的高效液相色谱法。方法以Zorbax XDB C18柱(250 mm×4.6 mm,5μm)为色谱柱,甲醇-水-乙腈(23∶41∶36)为流动相,流速为1.5 mL/min,柱温为40℃,检测波长为227 nm,进样量为10μL。样品经无水乙醇稀释后进样。结果紫杉醇峰与三杉尖宁碱(紫杉醇杂质Ⅰ)、7-表-10-去乙酰基紫杉醇(紫杉醇杂质Ⅱ)峰的分离度分别为2.40,1.67。紫杉醇质量浓度在9.6~96μg/mL范围内与峰面积呈良好线性关系(r=0.999 9),定量限为3 ng,紫杉醇亚微乳含量测定的平均回收率为99.99%,RSD为0.49%(n=9)。结论该方法简便、准确、专属性好,适用于紫杉醇亚微乳的含量测定。Objective To establish a high performance liquid chromatography（HPLC） method for the content determination of paclitaxel submicroemulsion. Methods The determination was performed on the Zorbax XDB C-18 column（250 mm^4.6 mm,5 μm） with the mobile phase of methanol -water- acetonitrile （23 ： 41 ： 36）. The flow rate was 1.5 mL/min. The column temperature was 40 ℃. The detection wavelength was 227 nm. and the injection volume was 10 μL. After the dilution by absolute ethanol the sample was injected. Results The separation degrees of paclitaxel with cephalomannine （paclitaxel impurity I） and 7-epi- 10-deacetyl-epipaclitaxel （paclitaxel impurity Ⅱ） peaks were 2.40 and 1.67. The mass concentration of paclitaxel in the range of 9.6-96 μg/mL showed a good hnear relationship with the peak area（r=0. 999 9）. The quantitation limit was 3 ng. The average recovery rate of paclitaxel submicroemulsion was 99. 99%, RSD was O. 49% （n =9）. Conclusion This method is simple, accurate and specific, which can be applicable for the content determination of paclitaxel submicroemulsion.

关 键 词：高效液相色谱法 紫杉醇 亚微乳 含量 

分 类 号：R927.2[医药卫生—药学] R979.1