Determination of paclitaxel 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, 5 μm), the mobile phase was methanol-acetonitrile-water(45:30:25, v/v), the detected wavelength was 227 nm, the colum temperature was 35℃, the flow rate was 1.0 ml/min, the injection volume was 20 μl. Results The linear concentration range was from 10 to 125 mg·L-1 of paclitaxel(R2=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.