RP-HPLC法测定多西他赛固体脂质纳米粒中多西他赛的含量

Determination of docetaxel in solid lipid nanoparticles by RP-HPLC

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 BDSC18（4．6mm×200mm，5μm），检测波长：228nm，流动相：乙腈-水（体积比为60：40），流速：1．0mL·min^-1，柱温：室温。结果多西他赛与其他组分分离良好，线性1．05～21．0mg·L^-1（r=0．9999），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。

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 mL·min^-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.