摘要
目的建立聚唾液酸衍生物P-G/泊洛沙姆407混合胶束中多西他赛含量的测定方法。方法采用溶剂法处理样品,并用HPLC法测定混合胶束中多西他赛的含量。色谱柱为Hypersil BDS C_(18)柱(200 mm×4.6 mm,5μm),检测波长为230 nm,流动相为乙腈-水(体积比55∶45),流速为1.0 m L·min^(-1),柱温30℃。结果体积分数为55%乙腈水溶液可完全破坏混合胶束且多西他赛回收率较高;空白胶束载体材料与多西他赛峰分离度良好,对多西他赛含量测定无干扰;多西他赛质量浓度在0.98~117.60 mg·L^(-1)内线性关系良好,r=0.999 8;日内、日间精密度RSD均小于2.0%;低、中、高3种质量浓度样品回收率均在95%~105%内,平均回收率为98.4%,RSD小于2.0%。结论该方法可用于混合胶束中多西他赛的含量测定。
Objective To establish a method for determination of the content of docetaxel in polysialic acid derivatives P-G and poloxamer 407 mixed micelles. Methods A HPLC method was applied to determinate the docetaxel loaded in micelles. The separation was achieved on the Hypersil BDS C_(18) column(200 mm × 4.6 mm, 5 μm). The Mobile phase consisted of acetonitrile-water(V∶V= 55∶45) at a flow rate of 1.0 m L·min^(-1) and the detection wavelength was set at 230 nm. The column temperature was kept at 30 ℃. Results The micelles were dissolved in 55% acetonitrile to destroy the micellar structure and dissociate docetaxel from mixed micelles. Docetaxel and carrier materials of micelles could be well separated. A good linear relationship was achieved for docetaxel in the range of 0.98~117.60 mg·L^(-1), r=0.999 8; the intra-day and inter-day precision RSD were less than 2.0%; The recoveries were between 95% and 105%. The average recovery was 98.4% and RSD less than 2.0%. Conclusion This method can be used for the determination of docetaxel loaded in the mixed micelles.
出处
《中国药剂学杂志（网络版）》
2016年第3期99-106,共8页
Chinese Journal of Pharmaceutics：Online Edition
基金
国家自然科学基金资助项目(81373334)
