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目的:本文建立了HPLC法测定盐酸二甲双胍中的有关物质双氰胺的含量。方法:采用Agilent SCX(250mm×4.6mm,5μm)色谱柱,以3.4%(W/V)磷酸二氢铵缓冲液(用磷酸调pH值至2.5)为流动相,流速1.0ml/min,检测波长218nm,柱温30℃,进样量10μl。结果:本法中双氰胺浓度在0.05～25.12μg/ml范围内呈良好线性关系,相关系数r=0.9999;可以用外标法对盐酸二甲双胍中的有关物质双氰胺进行准确测定。所测样品中盐酸二甲双胍的有关物质双氰胺均小于0.02%。结论:该方法灵敏、准确、可靠、方便、专属性好,适用于盐酸二甲双胍中有关物质双氰胺的含量测定。
Objective: To establish a HPLC method for the determination of dicyandiamide in metformin hydrochloride. Methods: Agilent SCX (250 mm × 4.6 mm, 5 μm) column was used. The mobile phase consisted of 3.4% (w / v) ammonium dihydrogen phosphate buffer (adjusted to pH 2.5 with phosphoric acid) Wavelength 218nm, column temperature 30 ℃, injection volume 10μl. Results: In this method, the dicyandiamide concentration in the range of 0.05 ~ 25.12μg / ml showed a good linear relationship with a correlation coefficient of r = 0.9999. The dicyandiamide in metformin hydrochloride can be accurately determined by external standard method. The measured samples of metformin hydrochloride related substances dicyandiamide were less than 0.02%. Conclusion: The method is sensitive, accurate, reliable, convenient and specific. It is suitable for the determination of dicyandiamide in metformin hydrochloride.