微柱离心-高效液相色谱法在测定注射用紫杉醇（白蛋白结合型)包封率中的应用

目的：采用微柱凝胶离心法（Micro-Column gel centrifugation，MCGE）-RPHPLC联用技术测定注射用紫杉醇（白蛋白结合型）（Paclitaxelfor Injection（Albumin Bound））的包封率。方法：采用Sephadex G-50微柱离心对样品进行前处理，分离结合型药物与游离药物。色谱条件：Pro C₁₈色谱柱（250 mm×4.6 mm，5 μm），乙腈-水（50∶50）为流动相，柱温30℃，流速1.0 mL·min^-1，检测波长228 nm。结果：紫杉醇在浓度范围0.000 1~0.060 1 mg·mL^-1与峰面积呈线性关系，r=0.999 9，平均回收率为98.6%，RSD为1.1%（n=9）。微柱离心法能将结合型药物与游离药物完全分离，测得注射用紫杉醇（白蛋白结合型）的平均包封率为93.6%（n=3）。结论：该方法简便快速、重复性良好，可用于测定注射用紫杉醇（白蛋白结合型）的包封率。

Application of micro-column gel centrifugation-HPLC method in determining the encapsulation efficiency of Paclitaxel for Injection(Albumin Bound)

OBJECTIVE To determine the entrapment efficiency of Paclitaxelfor Injection (Albumin Bound) by microcolumn gel centrifugation (MCGE) -RPHPLC.METHODS Sephadex G-50 Micro-Column Centrifugation-RPHPLC was performed to separate bound and free drugs.Chromatographic conditions:Pro C₁₈ column(250 mm×4.6 mm,5 μm),acetonitrile-water (50:50) as mobilephase.The column temperature was 30℃,the flow rate was 1.0 mL·min^-1,and the detection wave length was 228 nm.RESULTS The method showed a good linearity in the range of 0.000 1-0.060 1 mg·mL^-1 (r=0.999 9).The average recovery was 98.6%,the RSD was 1.1% (n=9).MCGE can completely separate the bound drug from the free drug,and the average encapsulation efficiency of Paclitaxel for Injection (Albumin Bound) is 93.6%(n=3).CONCLUSION The method is simple,rapid and reproducible,and can be used to determine the entrapment efficiency of paclitaxel for injection (albumin-bound).