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。
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.
出处
《沈阳药科大学学报》
CAS
CSCD
2004年第6期436-437,457,共3页
Journal of Shenyang Pharmaceutical University
关键词
盐酸二甲双胍缓释片
高效液相色谱法
双氰胺
metformin hydrochloride sustained-release tablet
HPLC
1-cyanoguanidine
