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Determination of the content and related substances in Docetaxel for injection by HPLC
Author(s): LI Jing, HUANG Yi-lan, ZHANG Dan, LI Xin-nan, YU Jin
Pages: 692-
694
Year: 2007
Issue:
6
Journal: WEST CHINA JOURNAL OF PHARMACEUTICAL SCIENCES
Keyword: 注射用多西他赛; HPLC; 有关物质; 含量测定;
Abstract: 目的 建立测定注射用多西他赛含量及有关物质的方法.方法 采用HPLC法,色谱柱为Luna C18(200 mm×4.6mm,5μm),流动相为乙腈-水(50:50),流速为1.0 ml·min-1,检测波长233 nm.结果 多西他赛浓度1~200μg·ml-1与峰面积的线性关系良好(r=0.9999),重复性试验的RSD=0.1%(n=6),高、中、低浓度的平均回收率为101.8%,有关物质检查的限量为2.0%,单个杂质限量为1.0%.结论 所建方法准确、简便、快速,适用于注射用多西他赛的质量控制.
Citations