HPLC法测定多西他赛及注射液的含量

Determination of Docetaxel and Its Injection by HPLC

建立了HPLC法测定多西他赛及注射液含量的新方法。用十八烷基硅烷键舍硅胶为填充剂（ZORBAXC18），以0．043mol／L醋酸铵溶液-乙腈（物质的量之比为45：55）为流动相；流速1．0mL／min，检测波长为232nm。注射液中辅料对主药无干扰；线性范围为10～270ug／mL；该方法精密度RSD=0．38％（n=6）；回收率为98．5％～101．3％；定量限为2ng。

An HPLC method was established in this paper for the determination of docetaxel and its injection. The Agilent（C18 150× 4.6 mm 5 um）column was used, the mobile phase was composed of buffer （0. 043 mol/L CH3COONH4）-CH3CN（45： 55）, the flow rate was 1.0 mL/min, and the detection wavelength was 232 nm. Alfuzosin in the injection was separated completely, the calibration curve for gadodiamide was linear in the range of 10-270 ug/mL, the RSD of precision was 0.38, the recovery was in the range of 98. 5%-101. 3% and the detection limit was 2 ng.