盐酸二甲双胍缓释片的相关物质研究

A study on the relative substances of metformin hydrochloride sustained-release tablets

目的 :测定盐酸二甲双胍缓释片的相关物质。方法 :采用HPLC法 ,色谱柱为SAULENTECHNIKPartisil-SCX(2 5 0mm×4 .6mm ,5 μm) ,流动相为 1.7%磷酸二氢铵溶液 ,用磷酸调pH值至 3.0 ,检测波长为 2 89nm ,对盐酸二甲双胍缓释片的相关物质进行测定 ,并确定其限量。结果 :本品的相关物质含量均小于 0 .1%。

Objective: To assay the relative substances in metformin hydrochloride sustained-release tablets. Methods: Assay the relative substances in metformin hydrochloride sustained-release tablets with HPLC, with SAULENTECHNIK Partisil-SCX column (250 mm×4.6 mm, 5 μm), 1.7% ammonium dihydrogen phosphate as mobile phase, pH value was adjusted to 3.0 with phosphoric acid, and detection wavelength of 289 nm. The limits of the relative substances were determined. Results: The content of relative substances of metformin hydrochloride sustained-release tablets was less than 0.1%.