紫杉醇注射液有关物质检查法的改进

Improvement of Related Substances Test Method for Paclitaxel Injection

目的:测定紫杉醇注射液的有关物质。方法:采用高效液相法。色谱柱:岛津ODS C18柱(250mm×4.6mm,5μm);流动相:甲醇-水-醋酸(70:30:0.1);流速:1ml/min;检测波长:227nm;柱温:35℃。并与国家药品标准中所载方法进行比较。结果:采用两种方法对三个批号的紫杉醇注射液有关物质进行检测,两者结果比较无显著性差异(P>0.05);且本法简便易行,结果准确。结论:本方法可以用来检测紫杉醇注射液的有关物质。

Objective;Determining the related substances in the Paclitaxel Injection. Methods：An HPLC method was established for the determination. Chromatography conditions： SHIMADZU ODS C18 column （250mm × 4. 6mm, 5um）; mobile phase ： methanol-water-acetic acid （70 ： 30 ： 0. 1 ） ; flow rate ： 1ml/min ; the detected wavelength ： 227nm ; column temperature ： 35℃. The method was used to compare with the national drug standard too. Results：After statistical analysis,there was no significant difference （P〉 0. 05）between these two method in determining three batches of the Paclitaxel Injections. This method is simple ,quick and the result is accurate. Conclusion：The method can be used to determine the related substances in the Paclitaxel Injection.