<p>Coenzyme Q10 and vitamin E are among the most widely consumed nutritional supplements in China owing to their antioxidant and other health-promoting properties. This study aimed to establish an accurate and efficient analytical method for the simultaneous determination of these two compounds in commercial softgel capsules, which is essential for rigorous quality control. Herein, a proton nuclear magnetic resonance (<sup>1</sup>H NMR) method was developed and validated using coumarin as an internal standard. Characteristic signals at 3.997 ppm for coenzyme Q10 and 2.621 ppm for vitamin E were selected for quantification. The method demonstrated excellent performance in terms of precision (relative standard deviation &lt;2%), specificity (resolution &gt;1.5), and stability (24-h variation &lt;3%). The validation results complied with the China Food and Drug Administration guidelines, demonstrating high accuracy. Application to products from four different manufacturers showed compound contents ranging from 98.2% to 102.4% of label amounts. These findings support <sup>1</sup>H NMR spectroscopy as a rapid, precise, and reliable approach for the simultaneous quality assessment of coenzyme Q10 and vitamin E formulations.</p>

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Simultaneous Quantification of Coenzyme Q10 and Vitamin E in Softgel Capsules Using Validated 1H NMR Spectroscopy

  • Yixuan Wang,
  • Mingming Yu,
  • Cong Wang

摘要

Coenzyme Q10 and vitamin E are among the most widely consumed nutritional supplements in China owing to their antioxidant and other health-promoting properties. This study aimed to establish an accurate and efficient analytical method for the simultaneous determination of these two compounds in commercial softgel capsules, which is essential for rigorous quality control. Herein, a proton nuclear magnetic resonance (1H NMR) method was developed and validated using coumarin as an internal standard. Characteristic signals at 3.997 ppm for coenzyme Q10 and 2.621 ppm for vitamin E were selected for quantification. The method demonstrated excellent performance in terms of precision (relative standard deviation <2%), specificity (resolution >1.5), and stability (24-h variation <3%). The validation results complied with the China Food and Drug Administration guidelines, demonstrating high accuracy. Application to products from four different manufacturers showed compound contents ranging from 98.2% to 102.4% of label amounts. These findings support 1H NMR spectroscopy as a rapid, precise, and reliable approach for the simultaneous quality assessment of coenzyme Q10 and vitamin E formulations.