高效液相色谱法测定草酸艾司西酞普兰中的有关物质

Determination of Related Substances of Escitalopram Oxalate with High Performance Liquid Chromatography

建立了草酸艾司西酞普兰中有关物质测定的高效液相色谱测定方法。采用高效液相色谱法,用十八烷基硅烷键合硅胶为填充剂;以0.05 mol/L磷酸二氢钾(0.5%三乙胺,用磷酸调节pH至4.0)—甲醇(45∶55)为流动相,流速为1.0 mL/min;检测波长为240 nm;柱温:25℃。草酸艾司西酞普兰与各杂质分离良好,最低检测限为5 ng。该方法简单、快速、准确、灵敏度高、专属性好,可用于草酸艾司西酞普兰原料有关物质的检查。

The method for the determination of related substance of escitalopram oxalate with high performance liquid chromalography was established.The chromatographic column was C18（150 mm×4.6 mm,5 μm）.The mobile phase consisted of 0.05 mol/L potassium dihydrogen phosphate solution（0.5% trithylamine,adjusted pH to 4.0 by phosphoric acid）-methanol（45：55）.The flow rate was 1.0 mL/min,the detection wavelength was 240 nm,and the column temperature was 25 ℃.Escitalopram oxalate was separated from the impurities thoroughly.The LOD was 5 ng for escitalopram oxalate.The method was simple,specific,sensitive and suitable for the determination of related substances of escitalopram oxalate.