RP-HPLC-凝胶分离法测定紫杉醇纳米微乳的包封率

RP-HPLC-sephadex separation determination of entrapment efficiency of paclitaxel nano-microemulsion

目的:建立 HPLC 法测定紫杉醇纳米微乳的包封率,并分析凝胶柱层析分离纳米微乳的可行性。方法:通过凝胶色谱法分离纳米粒和游离药物。采用反相高效液相色谱法,色谱柱为 ODS C_(18)柱(200 mm×4.6 mm,5 μm),流动相为甲醇-乙腈-水(2:9:10),流速1.0 mL·min^(-1),检测波长227 nm。结果:紫杉醇浓度存5～80μg·mL^(-1)范围内线性关系良好(r=0.9999);该方法回收率的 RSD 小于2.0%,日内和日间 RSD 均小于4%。凝胶柱对纳米粒的回收率试验,RSD 小于2.0%。结论:本方法简单、快速、准确,凝胶柱 Sephadex G-25分离纳米粒与游离药物所得结果稳定、重现性好,两者合用能准确地测定紫杉醇纳米微乳的包封率并可作为质量控制的手段之一。

Objective： To establish an RP - HPLC method to determine the entrapment efficiency of paclitaxel nano - microemulsion, and analyze the feasibility of the separation of nano - microemulsion by sephadex column chromatography. Method：The solid lipid nanospheres （SLN）and drug were separated by sephadex column chromatography. Using methanol -acetonitrile -water（2： 9：10）as mobile phase, the separation was performed on ODS C18 column（200 mm ×4. 6 mm,5 μm）at a flow rate of 1.0 mL · min^-1 and a wavelength of 227 nm. Results：The linear range for paclitaxel was 5 - 80 μg · mL^-1 （ r = 0. 9999 ）. The average recovery RSD was less than 2. 0% , and the intra - day RSD and inter - day RSD were less than 4.0%. The recovery RSD of sephadex column was less than 2. 0%. Conclusion： This HPLC method is simple, fast, accurate and the results of separating by sephadex column was stable,reproducible. The RP - HPLC - sephadex separation method can determine entrapment efficiency exactly as one factor of the quality control.