Simultaneous Determination of Metformin Hydrochloride, Cyanoguanidine and Melamine in Tablets by Mixed-Mode HILIC
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A simple and specific hydrophilic interaction liquid chromatography (HILIC) procedure for the quantification of metformin hydrochloride (MFH) and its impurities in bulk pharmaceuticals and finished dosage forms has been developed. The method is based on hydrophilic interaction of the analytes with silica. The influence of the weaker solvent, acetonitrile, pH and the nature and ionic strength of the buffer was studied. Linearity range and percent recoveries for MFH were 100–400 μg mL−1 and 100.62%, respectively. Good validation data were obtained for all compounds. The method separates impurities cyanoguanidine (CGD), melamine (MLN) and other degradation products with a run time of less than 13 min. Degradation studies involved thermal stress, hydrolysis at various pHs and chemical and photolytic oxidation.
KeywordsColumn liquid chromatography HILIC Metformin hydrochloride Melamine Cyanoguanidine Degradation studies
Authors wish to thank Mr. Anwar Saeed, Mr. Mahmoud Yusuf Jamjoom and Mr. Noor Sheriff for encouraging this work and providing required support in accomplishing the proposed HILIC method.
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