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目的:建立反相高效液相色谱法测定硫普罗宁的有关物质,并与药品标准收载的薄层色谱法进行比较。方法:采用Dia-monsil C18(150mm×4.6mm,5μm)色谱柱,流动相为0.1%磷酸溶液-甲醇(82∶18),流速1mL·min-1,检测波长210nm,进样量20μL。结果:硫普罗宁峰与相邻杂质峰能够完全分离。硫普罗宁浓度在0.42～16.82μg·mL-1范围内与峰面积呈良好的线性关系(r=0.9999),最低检测限为0.54ng。结论:反相高效液相色谱法与薄层色谱法比较,前者优于后者。反相高效液相色谱法操作简单,能准确、快速检测硫普罗宁的有关物质,可用于硫普罗宁的质量控制。
OBJECTIVE: To establish a reversed-phase high performance liquid chromatography (HPLC) method for the determination of related substances in tiopronin and to compare it with thin-layer chromatography (TLC). Methods: The mobile phase consisted of 0.1% phosphoric acid solution (82:18), flow rate 1 mL · min-1, detection wavelength 210 nm and injection volume 20 μL on a Dia-monsil C18 column (150 mm × 4.6 mm, 5 μm). Results: The peaks of tiopronin and the adjacent impurities can be completely separated. The concentration of tiopronin in the range of 0.42 ~ 16.82μg · mL-1 and the peak area showed a good linear relationship (r = 0.9999), the minimum detection limit of 0.54ng. Conclusion: The former is better than the latter by reversed-phase high-performance liquid chromatography and thin-layer chromatography. Reversed-phase high-performance liquid chromatography is simple, accurate and rapid detection of related substances of tiopronin can be used for the quality control of tiopronin.