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反相高效液相色谱法测定紫杉醇固体分散体中紫杉醇的含量

刘祥瑞, 吴科春, 张春晖, 张烜*, 张强

  

  1. 北京大学药学院 药剂学系, 北京 100083
  • 收稿日期:2006-12-15 修回日期:2007-05-10 出版日期:2007-06-15 发布日期:2007-06-15
  • 通讯作者: 张烜*

A RP-HPLC method for determination of paclitaxel in its solid dispersion

Xiang-Rui Liu, Ke-Chun Wu, Chun-Hui Zhang, Xuan Zhang*, Qiang Zhang   

  1. Department of Pharmaceutics, School of Pharmaceutical Sciences, Peking University, Beijing 100083, China
  • Received:2006-12-15 Revised:2007-05-10 Online:2007-06-15 Published:2007-06-15
  • Contact: Xuan Zhang*

摘要:

目的 优化和确定反相高压液相色谱法测定紫杉醇固体分散体中紫杉醇的含量。方法 色谱柱为Phenomenex ODS 3, 流动相为甲醇-乙腈-(40:30:30), 流速为1 mL·min–1, 柱温为40 °C, 检测波长为227 nm, 内标物为炔诺酮。结果 440 μg·mL–1浓度范围内, 紫杉醇浓度与紫杉醇/炔诺酮峰面积比之间具有良好的线性关系, r = 0.9999。加样回收率为98.42 %, RSD1.19 %结论 方法准确、可靠, 不但可以用于测定紫杉醇在固体分散体中的含量, 也可用于紫杉醇固体分散体溶出度的检查。

关键词: 紫杉醇, 紫杉醇, 紫杉醇, 固体分散体, 固体分散体, 固体分散体, 反相高效液相色谱法, 反相高效液相色谱法, 反相高效液相色谱法

Abstract: Aim To develop and validate a RP-HPLC method for the analysis of paclitaxel in a solid dispersion. Methods Paclitaxel and the internal standard norethisterone were separated using a Phenomenex ODS 3 column and monitored at a wavelength at 227 nm. The isocratic mobile phase consisting of methanol-acetonitrile-water (40:30:30, V/V) was pumped at a flow-rate of 1.0 mL·min–1. The dissolution studies were performed according to published studies. Results Under these chromatographic conditions, the calibration curve was linear in the range of 4–40 μg·mL–1 with the correlation coefficient of 0.9999. The mean recovery was 98.42 % (RSD = 1.19%). At the 60 min time point, the dissolution of paclitaxel from the solid dispersion was nearly 100 %, however, the original form of paclitaxel was about 30%. Conclusion The method was proven to be specific, accurate and precise for determining the dissolution of paclitaxel from solid dispersion.

Key words: Paclitaxel, Paclitaxel, Solid dispersion, Solid dispersion, RP-HPLC, RP-HPLC

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Supporting: *Corresponding author. Tel.: 86-10-82802683; fax: 86-10-82802791