RP-HPLC法测定多西他赛固体脂质纳米粒中多西他赛的含量

目的建立RP-HPLC法测定多西他赛固体脂质纳米粒中多西他赛的含量。方法色谱柱:Century SIL BDS C18(4.6 mm×200 mm,5μm),检测波长:228 nm,流动相:乙腈-水(体积比为60∶40),流速:1.0 mL.min-1,柱温:室温。结果多西他赛与其他组分分离良好,线性1.05~21.0 mg.L-1(r=0.999 9),日内、日间精密度为1.12%、1.03%,平均回收率为99.3%,RSD=0.95%。结论可作为该制剂的质量控制方法。

Determination of docetaxel in solid lipid nanoparticles by RP-HPLC

Objective To develop a RP-HPLC method for determination of docetaxel in solid lipid nanoparticles.Methods Separation was performed using a Century SIL BDS C18(4.6 mm×200 mm,5 μm),the detection wavelength was set at 228 nm.The mobile phase consisted of acetonitrile-water(V∶V=60∶40) at a flow-rate of 1.0 mL·min-1 and the column temperature was kept at the room temperature.Results Docetaxel can be well separated from other components.A linearity was obtained from 1.05 to 21.0 mg·L-1 of docetaxel with a good correlation(r=0.999 9).The intra-day and inter-day precision were 1.12% and 1.03% respectively,and the average recoveries was 99.3% with RSD of 0.95%(n=3).Conclusions The method is rapid,simple and accurate and reliable for the determination of docetaxel in solid lipid nanoparticles.