HPLC determination of metformin hydrochloride-related substances / 浙江大学学报·医学版

ABSTRACT

<p><b>OBJECTIVE</b>To develop a HPLC assay for the determination of metformin hydrochloride-related substances.</p><p><b>METHODS</b>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 (6040) (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 (5545)(pH=5.5). The detection wavelength was 232 nm, and the running speed was 0.8 ml min(-1) at room temperature.</p><p><b>RESULT</b>Good resolution of dicyandiamide and main peak was obtained. The test results were reproducible.</p><p><b>CONCLUSION</b>The method is simple, rapid and suitable for the determination of dicyandiamide and other metformin hydrochloride-related substances.</p>