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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 gradient elution HPLC method for the determination of related substances in tiopronin injection. Methods: The mobile phase consisted of 0.1 mol·L-1 potassium dihydrogen phosphate solution (adjusted to pH 3.2 with phosphoric acid) and methanol as mobile phase using a C18 column with a flow rate of 1.0 mL · min-1 and a detection wavelength of 210 nm. Results: This method can quickly and effectively separate the relevant substances in the injection of tiopronin. Conclusion: The method is sensitive, accurate and specific.