目的 建立HPLC法測(cè)定依維莫司原料藥中依維莫司。方法 采用Hypersil-ODS C₁₈色譜柱(250 mm×4.6 mm, 5 μm);流動(dòng)相:乙腈-水(70:30);檢測(cè)波長:276 nm;柱溫:50 ℃;體積流量:0.8 mL/min;進(jìn)樣量:10 μL。結(jié)果 依維莫司在63~1 008 μg/mL線性關(guān)系良好(r＝0.999 7), 平均回收率為100.45%, RSD值為0.64%(n＝9)。結(jié)論 所建立的操作簡便, 專屬性強(qiáng), 可用于依維莫司原料藥的質(zhì)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.