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

Abstract

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 a R² 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.

Keywords:

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

Disclosure statement

The authors declare that they have no competing interests.

Ethics statement

All procedures performed in this study involving mice were in accordance with experimental animal regulations of China . All experimental animal protocols were reviewed and approved by the institutional Committee for the use of laboratory animals.

Additional information

Funding

This work was supported by the National Natural Science Foundation of China with grant numbers 31873006 and 31572556; the Incubation Project on State Key Laboratory of Biological Resources and Ecological Environment of Qinba Areas (grant Number SLGPT2019KF04-04); the Key Program for International S and T Cooperation Project of Shaanxi Province with grant number 2017KW-ZD-10; and FCT I.P, the Minist erio da Ci≖ncia Tecnologia e Ensino Superior (MCTES), the European Regional Development Fund (ERDF) with grant number POCI-01-0145-FEDER-007569.