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Peer-reviewedCC BY-NC-ND 4.0ACS Omega

USP Standards for Dietary Ingredients Derived from Mate and Guayusa Leaves: A Quality by Design Approach to Method Development and Validation for the Simultaneous Determination of Methylxanthines and Hydroxycinnamoylquinic Acids

  • Salika Jeelani1
  • Greg Winter1
  • Natalia Kouznetsova1
  • Maria J. Monagas1
  1. 1United States Pharmacopeial Convention (USP) , , 12601 Twinbrook Parkway , , ,
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Abstract

Mate (or yerba mate, Ilex paraguariensis) and guayusa (Ilex guayusa), both members of the Aquifoliaceae family and traditionally consumed as herbal teas in South America, are rich in methylxanthines and hydroxycinnamoylquinic acids that may provide stimulant and antioxidant properties for use in beverages and dietary supplements. This work demonstrates an analytical quality-by-design (AQbD) approach to developing a UHPLC method and sample preparation procedure for the simultaneous quantification of these compounds in mate and guayusa leaves and their extracts. Using AQbD principles, critical method attributes and parameters were defined and optimized through design of experiments to understand variable interactions, establish robustness within the method operable design region, and experimentally confirm the selected conditions. The resulting UHPLC-DAD method separates three methylxanthines and nine hydroxycinnamoylquinic acids within 12 min and was validated per ICH and USP <1225> guidelines, demonstrating specificity, linearity, precision, accuracy, robustness, and reliable relative response factors. Overall, the AQbD framework enabled the development of a robust method suitable for determining these analytes in a variety of dietary ingredients derived from Mate and Guayusa leaves.

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Cite

BibTeXRIS
BibTeX
@article{jeelani2026standards,
  title = {{USP Standards for Dietary Ingredients Derived from Mate and Guayusa Leaves: A Quality by Design Approach to Method Development and Validation for the Simultaneous Determination of Methylxanthines and Hydroxycinnamoylquinic Acids}},
  author = {Salika Jeelani and Greg Winter and Natalia Kouznetsova and Maria J. Monagas},
  journal = {ACS Omega},
  year = {2026},
  month = oct,
  doi = {10.1021/acsomega.6c04044},
  url = {https://pubs.acs.org/acsodf/article/doi/10.1021/acsomega.6c04044/5454980/USP-Standards-for-Dietary-Ingredients-Derived-from},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - USP Standards for Dietary Ingredients Derived from Mate and Guayusa Leaves: A Quality by Design Approach to Method Development and Validation for the Simultaneous Determination of Methylxanthines and Hydroxycinnamoylquinic Acids
AU  - Salika Jeelani
AU  - Greg Winter
AU  - Natalia Kouznetsova
AU  - Maria J. Monagas
PY  - 2026
DA  - 2026/10/21
JO  - ACS Omega
DO  - 10.1021/acsomega.6c04044
UR  - https://pubs.acs.org/acsodf/article/doi/10.1021/acsomega.6c04044/5454980/USP-Standards-for-Dietary-Ingredients-Derived-from
AB  - Mate (or yerba mate, Ilex paraguariensis) and guayusa (Ilex guayusa), both members of the Aquifoliaceae family and traditionally consumed as herbal teas in South America, are rich in methylxanthines and hydroxycinnamoylquinic acids that may provide stimulant and antioxidant properties for use in beverages and dietary supplements. This work demonstrates an analytical quality-by-design (AQbD) approach to developing a UHPLC method and sample preparation procedure for the simultaneous quantification of these compounds in mate and guayusa leaves and their extracts. Using AQbD principles, critical method attributes and parameters were defined and optimized through design of experiments to understand variable interactions, establish robustness within the method operable design region, and experimentally confirm the selected conditions. The resulting UHPLC-DAD method separates three methylxanthines and nine hydroxycinnamoylquinic acids within 12 min and was validated per ICH and USP <1225> guidelines, demonstrating specificity, linearity, precision, accuracy, robustness, and reliable relative response factors. Overall, the AQbD framework enabled the development of a robust method suitable for determining these analytes in a variety of dietary ingredients derived from Mate and Guayusa leaves.
SN  - 2470-1343
ER  -