反相HPLC法测定temsirolimus原料药的含量  

Determination of temsirolimus by RP-HPLC

作　　者：马海霞[1] 李进[2,3] 邹祥[1] 

机构地区：[1]西南大学药学院,重庆制药过程与质量控制工程技术中心,重庆400715 [2]泸州职业技术学院 [3]西南大学药学院,泸州646000

出　　处：《中国抗生素杂志》2014年第2期128-130,共3页Chinese Journal of Antibiotics

基　　金：国家新药创制重大专项(2010ZX09401-306-4-4);西南大学博士基金(SWU109034);重庆市制药过程与质量控制工程技术研究中心能力提升项目(CSTC2012gg-yyjsb10002-33)

摘　　要：目的建立HPLC方法测定temsirolimus的含量。方法采用HypersiODSC18色谱柱（250mm×4．6mm，5μm），以乙腈和水为流动相梯度洗脱，流速为0．6mL／min，检测波长为277nm，柱温为60℃。结果在所选色谱条件下，主药与有关物质能较好分离，temsirolimus在52～1040μg／mL范围内，线性关系良好，回归方程Y＝34．C44X＋116．21（r=0．9992），方法回收率为100．74％，最低检测限为25ng／mL，样品溶液至少在8h内稳定。结论所建立的分析方法简便可行，可用于temsirolimus原料药的质量控制。Objective To establish an RP-HPLC method for the determination of temsirolimus. Methods The separation was performed on a Hypersil ODS C18（250mm×4.6mm, 5μm） column with gradient elution. The mobile phase was consist of acetonitrile-water. The flow rate was 0.6mL/min; the detection wavelength was at 277nm; the column temperature was 60℃. Results Temsirolimus and its related substances were completely separated by the method with a good linear range of 52-1040μg/mL and the regression equation was Y=34.044X＋ 116.21 （r=0.9992, n=7）, the average recovery was 100.74%, and the limit of detection was 25ng/mL. The temsirolimus in the sample solution kept stable within 8h. Conclusion The method is simple, sensitive and accurate. It can be used effectively for quality control of temsirolimus.

关 键 词：TEMSIROLIMUS 反相高效液相色谱法 含量测定 

分 类 号：R979.1[医药卫生—药品]