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目的 :建立一种新的测定二甲双胍有关物质的 HPL C法。方法 :采用色谱柱 Polaris C1 8柱 (2 5 0 mm× 4 .6 m m) ;检测波长 2 18nm;流量 1ml/ min,比较流动相中各有关因素对色谱行为的影响。结果 :优选出适宜流动相为含 0 .0 5 m ml/ L 十二烷基磺酸钠、1%三乙胺、0 .0 6 6 7mol/ L 磷酸二氢钾、5 %乙腈、以 6 m ol/ L 氢氧化钾和磷酸调 p H3.0的水。结论 :采用本流动相系统 ,改善了二甲双胍与主要有关物质双氰胺的分离 ,提高了色谱分析适应性
Objective: To establish a new HPL C method for the determination of metformin-related substances. Methods: The chromatographic behavior was determined by Polaris C1 8 column (250 mm × 4.6 μm), detection wavelength at 2 18 nm and flow rate of 1 ml / min. Results: The optimal mobile phase consisted of 0.05 mol / L sodium dodecyl sulfate, 1% triethylamine, 0.6067 mol / L potassium dihydrogen phosphate, 5% acetonitrile and 6 m ol / L potassium hydroxide and phosphoric acid p H3.0 water. Conclusion: The mobile phase system is used to improve the separation of metformin and its related substance dicyandiamide and improve the chromatographic analysis adaptability