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HPLC法测定盐酸二甲双胍缓释片中杂质双氰胺含量
Determination of the content of 1-cyanoguanidine of the metformin hydrochloride sustained-release tablets by HPLC
【摘要】 目的测定盐酸二甲双胍缓释片中双氰胺的含量。方法采用HPLC法。色谱柱为hypersilSCX柱 (4 6mm× 15 0mm ,5 μm) ;流动相 :0 4 3mol·L-1磷酸二氢铵缓冲液 (pH 2 5 ) ;检测波长 :2 18nm。结果盐酸二甲双胍的理论塔板数大于 2 0 0 0 ,盐酸二甲双胍与其杂质双氰胺的分离度不低于 1 5。结论HPLC法适用于盐酸二甲双胍缓释片中杂质双氰胺的含量测定
【Abstract】 Objective To determine the content of the related substances of the metformin hydrochloride sustained-release tablets by HPLC.Methods Chromatographic condition included the SCX column（（4.6 mm）×（150 mm）,（5 μm）） and mobile phase consisting of (0.43 mol·L-1) ammonium dihydrogen phosphate. The detection wavelength was set at （218 nm）.Results The theoretical plate number of the metformin hydrochloride is over （2 000）,the resolution from 1-cyanoguanidine is higher than 1.5.Conclusion This method can be used properly to test 1-cyanoguanidine.
【Key words】 metformin hydrochloride sustained-release tablet； HPLC； 1-cyanoguanidine；
- 【文献出处】 沈阳药科大学学报 ,Journal of Shenyang Pharmaceutical University , 编辑部邮箱 ,2004年06期
- 【分类号】R927
- 【被引频次】21
- 【下载频次】480