HPLC测定替米沙坦的含量和有关物质

Determination of Telmisartan and its related substances by HPLC

目的 建立新药替米沙坦含量测定和有关物质的检查方法 ,并对该药进行质量控制和稳定性研究。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 ,甲醇 - 0 .0 3mol·L-1 磷酸二氢钾溶液 (6 0∶4 0 )为流动相 ,并用磷酸调pH3.5 ,检测波长 2 95nm。结果 在选定的色谱条件下 ,主要合成的中间体和降解产物可以完全分离。结论 所用方法灵敏、准确。

OBJECTIVE To control quality and study stability of Telmisartan, a method for determination of Telmisartan and related substances was established. METHODS The liquid chromatography was carried out using a Luna 5 μ C 18 (2) column (150 mm×4.6 mm, ID) with detective wavelength at 295 nm.The mobile phase consisted of methanol- solution of monopotassium phosphate ( 0.03 mol·L -1 ) (60∶40) with pH 3.5.RESULTS The intermediates and degraded substances could be separated. Three batches of sample were determined.CONCLUSION The method was sensitive, accurate and reliable. It can be used to determine the content of Telmisartan and its related substances.