摘要
目的：建立高效液相色谱法测定复方盐酸二甲双胍片中有关物质双氰胺。方法：采用phenomenex C18枉（250×4．6mm），柱温35℃．甲醇-5mmoI磷酸二氢钾溶液（含10mmol辛烷磺酸钠，用1．5mol／L的磷酸溶液调pH至3.0）（55：45）为流动相，检测波长为215nm。结果：线性范围为0．0628-0．1503μg／ml。结论：该方法灵敏，专属,分离度好，并能有效控制复方盐酸二甲双胍片中有关物质双氰胺。
Objective：To establish an HPLC method for determining relative substance dicyanodiamide in Compound Metformin Hydrochlorlde Tablets. Methods：Using a column packed with C18 （250 × 4.6mm）and kept 35℃. Methanol-Smmol potassium dihydrogen phosphate solution（contain 10mmol sodium octanesulfonate,adjusted to pH 3.0 with 1.5mol/L phosphoric acid） （55 ： 45）as mobile phase, detected at 215nm. Results：The calibration curve was linear within the range of 0. 0628- 0. 1503 μg/ml. Conclusion：This method is sensitive,speclfic and showing also good separating degree. It can be used for quality control of relative substance dicyanodiamide in Compound Metformin Hydrochloride Tablets.
出处
《中国药品标准》
CAS
2006年第4期44-46,共3页
Drug Standards of China
关键词
HPLC
有关物质
双氰胺
HPLC
relative substances
Dicyanodiamide
