摘要
目的:检测盐酸二甲双胍片剂中的双氰胺及其它有关物质。方法:HPLC色谱条件:色谱柱为SHI-MADZU-VPODS柱(250×4.6mm,5μm);双氰胺流动相:甲醇∶10mmol/L磷酸二氢钠(含1mmol/L十二烷基硫酸钠)(60∶40)用磷酸调pH至5.5;检测波长:218nm,流速:0.8ml/min。其他有关物质流动相:甲醇∶10mmol/L磷酸二氢钠(含1mmol/L十二烷基硫酸钠)(55∶45)用磷酸调pH至5.5;检测波长:232nm;流速:0.8ml/min。结果:双氰胺与二甲双胍主峰可以达到良好的分离,试验结果重现性好。结论:本法灵敏度高,专属性强,分离较好,操作简便、快速,结果准确、可靠。
Objective： To develop a HPLC assay for the determination of metformin hydrochloride-related substances. Methods： The separation was performed on SHIMADZU VP-ODS （250 4.6 mm, 5 μm） column. The mobile phase of dicyandiamide was composed of methyl alcohol-1 mmol · L^-1 sodium dodecylsulfate in 10 mmol ·L^-1 phosphate salt solution （60： 40） （pH=5.5）. The mobile phase of other related substances was composed of methyl alcohol-1 mmol · L^-1 sodium dodecysulfate in 10 mmol · L^-1 phosphate salt solution （55 ： 45）（pH=5.5）. The detection wavelength was 232 nm,and the running speed was 0. 8 ml min^-1 at room temperature. Results： Good resolution of dicyandiamide and main peak was obtained. The test results were reproducible. Conclusion： The method is simple ,rapid and suitable for the determination of dicyandiamide and other metformin hydrochloriderelated substances.
出处
《浙江大学学报（医学版）》
CAS
CSCD
2005年第4期368-371,共4页
Journal of Zhejiang University(Medical Sciences)
关键词
二甲双胍/分析
色谱法
高效液相
双氰胺
相关物质
Metfomin/anal
Chromatography
high pressure liquid
Dicyandiamide
Related substance
作者简介
王临润（1963-），男，副主任药师，从事临床药理工作；E—mail：Linrunw@Yahoo．com．cn
