RP—HPLC法测定紫杉醇注射液的含量及有关物质

目的建立高效液相色谱法测定紫杉醇注射液的含量及有关物质的方法。方法应用HPLC法，色谱柱为Hypersil BDSC18（4．6／mm×250mm，5μm），检测波长为227nm，柱温35℃，流速为1．0ml／min，进样量为20μl，流动相为甲醇-乙腈-水（45：30：25，v／v）。结果紫杉醇浓度在10-125mg。L^-1的范围内，溶液的浓度与色谱峰面积线性关系良好（R^2=0．9998，n=6）。精密度试验RSD为0．17％（n=5），平均加样回收率为99．33％，RSD=0．38％。结论本方法简便、准确、快速、重复性好，可用于紫杉醇注射液的含量测定和有关物质检查。

Determination of pacUtaxel injection and its related substances by HPLC

Objective To establish a method for the determination of paclitaxel injection and its related substances by High Performance Liquid Chromatography（HPLC）. Methods The determination was performed on the following conditions： the colum was Hypersil BDS C18（4.6 mm×250 mm, 5μm）, the mobile phase was methanol-acetonitrile-water （45：30：25, v/v）, the detected wavelength was 227 nm, the coluna temperature was 35℃ , the flow rate was 1.0 ml/min, the injection volume was 20μl. Results The linear concentration range was from 10 to 125 mg·L^-1 of paclitaxel（R^2=0.9998, n=6）. The RSD of precision test was 0.17%. The average recovery was99.33 %, RSD=0.38%. Conclusion The method is simple, accurate, rapid and reproducible. It can be used to detect the content of paclitaxel injection and its related substances.