A UPLC Method for Analysis of Metformin and Related Substances by Hydrophilic Interaction Chromatography (HILIC)
نویسندگان
چکیده
IN T RO DU C T IO N Metformin hydrochloride is an anti-diabetic drug typically administered orally while treating non-insulin dependant (type 2) diabetes mellitus.1 It is one of the most widely-used oral antidiabetic drugs worldwide, with over 48 million generic formulation prescriptions filled in the United States alone.2 Liquid chromatographic analysis of metformin and related impurities presents a challenging task due to the highly polar characteristics of the molecules and the low UV absorbance of the analytes. These challenges limit the options to manipulate selectivity during method development, especially with reversedphase (RP) chromatography. Numerous methods are cited utilizing a variety of techniques such as ion chromatography, hydrophilic interaction chromatography (HILIC), and RP LC methodologies reporting run times up to 30 minutes.1,3,4
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