RP-HPLC梯度洗脱法测定复方替米沙坦片的有关物质  

Determination of the Related Substances in Compound Telmisartan Tablets by RP-HPLC Gradient Elution Method

作　　者：王兵 陈文 殷学治 

机构地区：[1]常州制药厂有限公司,江苏常州213018

出　　处：《广东化工》2010年第12期227-228,共2页Guangdong Chemical Industry

摘　　要：目的:建立RP-HPLC梯度洗脱法测定复方替米沙坦片的有关物质。方法:使用Waters C18柱(4.6 mm×250 mm,5μm)色谱柱,采用线性梯度洗脱;流动相A为乙腈,B为0.05 mol/L磷酸二氢钾缓冲液(用磷酸调pH=4.0);检测波长272 nm;流速1.0 mL/min;柱温:30℃。结果:复方替米沙坦片主成份峰与各杂质峰分离良好,理论塔板数以氢氯噻嗪计大于3000,以替米沙坦计大于7000。结论:本方法灵敏高、专属强,可用于复方替米沙坦片有关物质及降解产物的检查。Objective： To establish an RP-HPLC gradient elution method for determining the related substances in compound telmisartan tablets. Methods： The determination of the related substances in compound telmisartan tablets was performed on a Waters C18 column （4.6mm×250mm, 5μm）. The mobile phase A was acetonitrile and the mobile phase B was 0.05 mol/L Potassium dihydrogen phosphate buffer （adjusted pH to 4.0 with phosphoric acid）. The flow rate was 1.0 mL·min^-1. Ultraviolet absorption detector was set at 272 nm and column temperature at 30℃. Results： The main components ＇peak and the impurities＇ peak were departed well in compound telmisartan tablets, theoretical plate number of hydrochlorothiazide 〉 3000, the theoretical plate number of telmisartan〉 7000. Conclusions： The method had high sensitivity, good Specificity for detecting the related substances and its degradation products of the compound telmisartan tablets.

关 键 词：复方替米沙坦片 RP—HPLC 梯度洗脱 有关物质 

分 类 号：O65[理学—分析化学]