HPLC法梯度洗脱测定硫普罗宁注射液中的有关物质

HPLC determination by gradient elutionof related substances in tiopronin injection

目的:建立梯度洗脱的HPLC法测定硫普罗宁注射液中有关物质。方法:使用C18色谱柱,以0.1 mol.L-1磷酸二氢钾溶液(用磷酸调节pH至3.2)-甲醇为流动相,梯度洗脱,流速1.0 mL.min-1,检测波长210 nm。结果:本法可快速有效分离硫普罗宁注射液中各有关物质。结论:本方法灵敏、准确,专属性强。

Objective：To establish a method for the determination of related substances in tiopronin injection by using gradient elution of HPLC. Methods：C18 column was adopted;Mobile phase consisted of buffer（pH 3.2） – methanol with gradient elution at a flow rate of 1.0 mL·min-1,and the detection wavelength was 210 nm. Results：Tiopronin and its related substance were oboviously separated under the chromatographic system decribed above. Conclusion：The method is sensitive,accurate and specific.