HPLC测定三苯甲基氯沙坦的有关物质

Determination of Related Substances in Trityl Losartan by HPLC

摘要: 目的建立高效液相色谱法测定三苯甲基氯沙坦有关物质。方法采用Lichrospher RP-select B 60A(250 mm×4.0 mm，5 μm)色谱柱；流动相：采用0.01 mol·L^-1的磷酸二氢钠溶液(20%的磷酸调节pH 2.5)和乙腈为流动相进行梯度洗脱；流速：1.5 mL·min^-1；柱温：35 ℃；检测波长：230 nm。结果样品中的杂质均能很好检出，各杂质与主峰之间的分离度良好。结论该方法简单快速，专属性强，结果准确，可用作三苯甲基氯沙坦有关物质检查。

Abstract: OBJECTIVE To establish an HPLC method for determination of related substances in trityl losartan. METHODS Lichrospher RP-select B 60A column (250 mm×4.0 mm, 5 μm)was used, the gradient mobile phase consisting of 0.01 mol·L^-1 sodium dihydrogen phosphate(pH=2.5)-acetonitrile with a flow rate of 1.5 mL·min^-1 was used. The column temperature was kept at 35 ℃ and the detection wavelength was set at 230 nm. RESULTS Trityl losartan and related substances could be well isolated. CONCLUSION The method is simple, rapid, accurate and suitable for determinating the related substances in trityl losartan.