[HPLC determination of metformin hydrochloride-related substances].
To develop a HPLC assay for the determination of metformin hydrochloride-related substances.



The separation was performed on SHIMADZU VP-ODS (250 4.6 mm, 5 microm) column. The mobile phase of dicyandiamide was composed of methyl alcohol-1 mmol x L(-1) sodium dodecylsulfate in 10 mmol x L(-1) phosphate salt solution (60:40) (pH=5.5). The mobile phase of other related substances was composed of methyl alcohol-1 mmol x L(-1) sodium dodecysulfate in 10 mmol x 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.



Good resolution of dicyandiamide and main peak was obtained. The test results were reproducible.



The method is simple, rapid and suitable for the determination of dicyandiamide and other metformin hydrochloride-related substances.
Wang
Lin-run
LR
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China. Linrunw@Yahoo.com.cn
Huang
Ming-zhu
MZ
Zhu
Su-hui
SH
D002851:Chromatography, High Pressure Liquid; D006146:Guanidines / Q000032:analysis*; D007004:Hypoglycemic Agents / Q000737:chemistry*; D008687:Metformin / Q000737:chemistry*; D012680:Sensitivity and Specificity; D013607:Tablets
D006146:Guanidines; D007004:Hypoglycemic Agents; D013607:Tablets; D008687:Metformin; C004711:dicyandiamido