HPLC determination of metformin hydrochloride-related substances.
- Author:
Lin-run WANG
1
;
Ming-zhu HUANG
;
Su-hui ZHU
Author Information
- Publication Type:Journal Article
- MeSH: Chromatography, High Pressure Liquid; Guanidines; analysis; Hypoglycemic Agents; chemistry; Metformin; chemistry; Sensitivity and Specificity; Tablets
- From: Journal of Zhejiang University. Medical sciences 2005;34(4):368-371
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo develop a HPLC assay for the determination of metformin hydrochloride-related substances.
METHODSThe 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.
RESULTGood resolution of dicyandiamide and main peak was obtained. The test results were reproducible.
CONCLUSIONThe method is simple, rapid and suitable for the determination of dicyandiamide and other metformin hydrochloride-related substances.
