4.4 Article

Determination of Dehydroepiandrosterone in Dietary Supplements and Pharmaceutical Products by a Competitive Chemiluminescent Enzyme Immunoassay

Journal

ANALYTICAL LETTERS
Volume 54, Issue 5, Pages 842-853

Publisher

TAYLOR & FRANCIS INC
DOI: 10.1080/00032719.2020.1784913

Keywords

Dehydroepiandrosterone (DHEA); dietary supplements; high-performance liquid chromatography (HPLC); indirect competitive chemiluminescent enzyme immunoassay (ic-CLEIA); monoclonal immunoglobulin G antibody; pharmaceuticals

Funding

  1. National Natural Science Foundation of China [31873006, 31572556]
  2. Incubation Project on State Key Laboratory of Biological Resources and Ecological Environment of Qinba Areas [SLGPT2019KF04-04]
  3. Key Program for International S and T Cooperation Project of Shaanxi Province [2017KW-ZD-10]
  4. FCT I.P
  5. European Regional Development Fund (ERDF) [POCI-01-0145FEDER-007569]
  6. Minist erio da CiPncia Tecnologia e Ensino Superior (MCTES)

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A rapid immunoassay was established for the determination of DHEA in dietary supplements and pharmaceutical products, demonstrating high sensitivity and reliability.
Dehydroepiandrosterone (DHEA), an endogenous steroid hormone, is available in dietary supplements and pharmaceutical products. However, the contents of DHEA in many products are inconsistent with label claims. Excess consumption of DHEA may cause extensive adverse reactions. This study aimed to establish a rapid immunoassay for the determination of DHEA in dietary supplements and pharmaceutical products. An indirect competitive chemiluminescent enzyme immunoassay (ic-CLEIA) was developed based on the generated monoclonal antibody. The limit of detection for DHEA was 0.21 ng/mL with a linear working range from 0.25 to 10 ng/mL with aR(2)value equal to 0.989. The recoveries of the spiked samples as tablets, capsules, and lyophilized powders were from 84.0% to 102.4% (intra-assay) and 89.5% to 105.5% (inter-assay). The results were validated by high-performance liquid chromatography (HPLC) with a high correlation coefficient of 0.937, demonstrating that the developed ic-CLEIA was sensitive for the determination of DHEA in dietary supplements and pharmaceutical products.

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