Comprehensive Evaluation of Over-the-Counter Magnesium Tablets Using Quality Control Analysis, EDTA Titration, ICP-OES, and UV/Vis Spectroscopy

Disciplines

Analytical Chemistry

Abstract (300 words maximum)

Over-the-counter supplements are often underregulated by the FDA, causing the label claims made by manufacturers to be inaccurate. The objective of the research was to determine the accuracy and uniformity of the API in over-the-counter supplements. In this study, a pharmaceutical analysis of magnesium tablets was performed according to USP guidelines. Three brands of magnesium oxide tablets were analyzed. Friability, disintegration, and dissolution testing were conducted. The dissolution test was performed to investigate the rate of drug release when in conditions similar to the human stomach. Two dissolution tests were performed, one in degassed water and one in degassed 0.1 M HCl. An initial assay of the tablets was conducted through an EDTA titration, and additional assays were done using UV/Vis and ICP-OES. One brand of tablets failed the friability test, while the other two brands passed. All three tablet brands passed the disintegration test. For all three tablet brands tested, the assay using EDTA titration indicated that the actual amount of magnesium was close to the label claim. Further results will be described.

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Academic department under which the project should be listed

CSM – Chemistry and Biochemistry

Primary Investigator (PI) Name

Dr. Marina Koether

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Comprehensive Evaluation of Over-the-Counter Magnesium Tablets Using Quality Control Analysis, EDTA Titration, ICP-OES, and UV/Vis Spectroscopy

Over-the-counter supplements are often underregulated by the FDA, causing the label claims made by manufacturers to be inaccurate. The objective of the research was to determine the accuracy and uniformity of the API in over-the-counter supplements. In this study, a pharmaceutical analysis of magnesium tablets was performed according to USP guidelines. Three brands of magnesium oxide tablets were analyzed. Friability, disintegration, and dissolution testing were conducted. The dissolution test was performed to investigate the rate of drug release when in conditions similar to the human stomach. Two dissolution tests were performed, one in degassed water and one in degassed 0.1 M HCl. An initial assay of the tablets was conducted through an EDTA titration, and additional assays were done using UV/Vis and ICP-OES. One brand of tablets failed the friability test, while the other two brands passed. All three tablet brands passed the disintegration test. For all three tablet brands tested, the assay using EDTA titration indicated that the actual amount of magnesium was close to the label claim. Further results will be described.