HPLC法测定盐酸舍曲林片的有关物质

Determination of related substances of Sertraline Hydrochloride Tablets by HPLC

目的建立高效液相色谱法检测盐酸舍曲林片中有关物质的方法。方法采用Waters Symmetry C18色谱柱,以含有磷酸、磷酸二氢钾溶液和乙腈的不同比例的混合液为流动相进行梯度洗脱,流速为1.0 mL·min-1,检测波长为210 nm,柱温为25℃,进样量为20μL。结果有关物质与盐酸舍曲林主成分色谱峰分离良好。结论该方法操作简便、重复性好、专属性强,可作为盐酸舍曲林片质量控制方法。

Objective To establish an HPLC method for the determination of the related substances of Sertraline Hydrochloride Tablets. Methods A gradient elution was carried out on a Waters Symmetry C18 column with mixture of phosphoric acid and potassium dihydrogen phosphate solution and acetonitrile as mobile phase,and the flow rate was 1. 0 mL ·min^ - 1 . The detection wavelength was 210 nm,the column temperature was 25 ℃,and the injection volume was 20 μL. Results The relevant substances were well separated from the chief agent. Conclusion The method was simple,repeat-able and specific,and can be used for the quality control of Sertraline Hydrochloride Tablets.