RP-HPLC梯度洗脱法测定替米沙坦中有关物质  

Determination of related substances in telmisartan by elution gradient RP-HPLC

作　　者：吴赟[1] 王成港[1] 张胜利 

机构地区：[1]天津药物研究院,天津300193 [2]施维雅(天津)制药有限公司,天津300457

出　　处：《现代药物与临床》2012年第3期229-231,共3页Drugs & Clinic

摘　　要：目的建立替米沙坦中有关物质的测定方法。方法采用反相高效液相色谱(RP-HPLC)法,使用DikmaDiamonsilC18色谱柱(150mm×4.6mm,5μm),[磷酸二氢钾-戊烷磺酸钠缓冲液(pH3.0)]-[甲醇-乙腈(20:80)]线性梯度洗脱,检测波长为230nm,体积流量为1.0mL/min,柱温为35℃。结果在上述色谱条件下,5种杂质能与替米沙坦有效地分离,分离度大于1.5,检出限为0.1ng。结论使用本方法测定替米沙坦中有关物质,能有效检出特定杂质,方法准确、快速、重复性好。Objective To establish a method for the determination of related substances in telmisartan.Methods The RP-HPLC method was carried out using a Dikma Diamonsil C18 column（150 mm×4.6 mm,5 μm）,the mobile phase consisted of KH2PO4-pentane sulfonic acid sodium salt buffer（pH 3.0） and methanol-acetonitrile（20：80） with linear gradient elution,the detective wavelength was at 230 nm with the flow rate of 1.0 mL/min and the temperature at 35 ℃.Results Five impurities were effectively separated from telmisartan with separating degree（R）1.5,and detection limit 0.1 ng.Conclusion The related substances could be determined from telmisartan by the method,and this method with better reproducibility is precise and rapid.

关 键 词：替米沙坦 有关物质 高效液相色谱 梯度洗脱 

分 类 号：R927.2[医药卫生—药学]