摘要
目的建立新药替米沙坦中有关物质的测定方法,以控制其质量。方法采用反相高效液相色谱法,以十八烷基硅烷键合硅胶为填充剂,乙腈0.01mol/L醋酸铵溶液(60:40)(用30%醋酸调节pH值至6.0)为流动相,检测波长为255nm。结果在本实验选定的色谱条件下,替米沙坦峰能与各主要合成中间体和降解产物峰有效分离,检测灵敏。结论本法简便、准确,重复性好,结果满意。
OBJECTIVE To control quality of telmisartan, a method for determination of the related substances of telmisartan was established. METHODS The reserved-phase high performances liquid chromatograpy was equipped with C_ 18 column (150mm× 4.6 mm,5μ) and DAD detector. The detective wavelength was set at 255nm. The mobile phase consisted of acetonitrile-0.01mol/L ammonium acetic(60:40), and was adjusted to pH6.0 with 30% acetic acid. RESULTS Telmisartan was separated with the intermediates and degraded substances efficiently. The repeatability and sensitivity of the analytical method was satisfactory. CONCLUTION A sensitive, simple and repeated method for detecting the related substances from telmisartan is developed and used to the quality control of telmisartan.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2005年第3期252-253,共2页
Chinese Journal of Modern Applied Pharmacy
