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Determination of magnesium stearate in capsule- or tablet-type supplements
Yoko Uematsu1, Mami Ogimoto, Junichirou Kabashima
1Tokyo Metropolitan Institute of Public Health, 3-24-1, Hyakunin-cho, Shinjuku-ku, Tokyo 169-0073, Japan. Yoko_Uematsu@member.metro.tokyo.jp
Journal of AOAC International
|April 28, 2006
Summary
A new method accurately measures magnesium stearate in supplements. Some products had high levels, suggesting potential adulteration with this common excipient.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
Background:
- Magnesium stearate is a widely used pharmaceutical excipient.
- Accurate quantification of magnesium stearate is crucial for supplement quality control.
Purpose of the Study:
- To develop a simple and reliable method for determining magnesium stearate content in solid dosage forms.
- To assess magnesium stearate levels in commercially available supplements.
Main Methods:
- Extraction of free stearic acid using tetrahydrofuran.
- Conversion of magnesium stearate to stearic acid via cation-exchange resin.
- Quantification of stearic acid using gas chromatography with a polar column.
Main Results:
- The developed method effectively determined stearic acid derived from magnesium stearate.
- Esters of stearic acid did not interfere with the analysis.
- Five out of twenty-five analyzed supplements showed magnesium stearate levels exceeding 2500 μg/g.
Conclusions:
- The developed gas chromatography method provides a straightforward approach for magnesium stearate determination.
- Elevated magnesium stearate levels in some supplements may indicate intentional admixture.
- Further investigation into supplement composition is warranted.
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