HPLC法测定依维莫司原料药中依维莫司  

Determination of everolimus in everolimus active pharmaceutical ingredient by HPLC

作　　者：孙莉君[1] 沈海梅 马海霞[1] 董大伟[1] 王越[1] 杨静[1] 

机构地区：[1]大庆市人民医院,黑龙江大庆163316 [2]哈尔滨莱博通药业有限公司,黑龙江哈尔滨150025

出　　处：《现代药物与临床》2015年第6期663-665,共3页Drugs & Clinic

摘　　要：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，5μm）；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：10μL。结果依维莫司在63～1008μg/mL线性关系良好（r＝0.9997），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 C18column 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 10μL.Results Everolimus had good linearity in the ranges of 63 — 1 008μg/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.

关 键 词：依维莫司原料药 依维莫司 高效液相色谱 

分 类 号：R927.2[医药卫生—药学]