HPLC法两种色谱柱测定盐酸二甲双胍缓释片中杂质的比较

The Comparison Between two HPLC Column for the Determination of the Impurity of Metformin Hydrochloride Sustained Release Tablets

目的建立盐酸二甲双胍缓释片中杂质的HPLC测定方法,采用两种类型色谱柱,并与2005版《中国药典》的HPLC法比较。方法采用Shiseido C18柱,流动相:以甲醇-5 mmol.L-1磷酸二氢钾溶液(含有10 mmol.L-1十二烷基磺酸钠,用磷酸调节pH至3.5±0.05)(64∶36),流量为1.0 ml.min-1,检测波长为218 nm。结果通过已知杂质双氰胺的外标法和自身对照法计算的盐酸二甲双胍缓释片中其它杂质均符合规定。结论与《中国药典》方法比较,此方法准确,且C18柱价格低廉。

AIM To develop a HPLC method for the determination of the impurity of mefformin hydrochloride sustained release tablets by two type columns, and compare with a HPLC method in 2005 Ch P. METHODS The determination was carried out on a C18 column. The mobile phase was composed of methanol-10 mmol·L^-1 sodium dodecylsufonate in 5 mmol·L^-1 potassium dihydrogen phosphate solution（ pH 3.5±0.05） （64：36） with the flow rate of 1.0 ml·min^-1. The detection wavelength was 218 nm. RESULTS With the method, the 1- cyanoguanidine and other impurities are all less than the limits. CONCLUSION In comparison with the HPLC method in 2005 Ch P, it is accurate and the column is less expensive.