目的 建立HPLC法测定依维莫司原料药中依维莫司。方法 采用Hypersil-ODS C₁₈色谱柱(250 mm×4.6 mm, 5 μm);流动相:乙腈-水(70:30);检测波长:276 nm;柱温:50 ℃;体积流量:0.8 mL/min;进样量:10 μL。结果 依维莫司在63~1 008 μg/mL线性关系良好(r＝0.999 7), 平均回收率为100.45%, RSD值为0.64%(n＝9)。结论 所建立的操作简便, 专属性强, 可用于依维莫司原料药的质量控制。

Objective To establish an HPLC method for determination of everolimus in everolimus active pharmaceutical ingredient. Methods The separation was performed on a Hypersil-ODS C₁₈ column with acetonitrile -water (70:30) as mobile phases. The detection wavelength was set at 276 nm. The column temperature was 50 ℃. The flow rate was 0.8 mL/min with injection volume of 10 μL. Results Everolimus had good linearity in the ranges of 63 — 1 008 μg/mL (r＝ 0.999 7). The average recovery was 100.45% with RSD 0.64% (n=9). Conclusion The method is simple and specific, and can be used effectively for quality control of everolimus active pharmaceutical ingredient.