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编号:10981356
盐酸二甲双胍缓释片的相关物质研究
http://www.100md.com 《广东药学院学报》 2004年第3期
盐酸二甲双胍,,盐酸二甲双胍;缓释片;高效液相色谱法;相关物质,1试剂与仪器,2实验方法,3结果,3讨论,参考文献
     摘 要 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SAULENTECHNIK Partisil-SCX(250 mm×4.6 mm,5μm),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289 nm,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%。

    关键词 盐酸二甲双胍;缓释片;高效液相色谱法;相关物质

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

    CHEN Yanzhong,LU Zhufen

    (Institute of Materia Medica, Guangdong College of Pharmacy, Guangzhou, Guangdong 510240)

    Abstract 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%. ......

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