HPLC法梯度洗脱测定硫普罗宁注射液中的有关物质

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.