Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

Primary and Secondary Evaluation of Method SJW-03

SJW-03: Determination of St. John’s wort Components in Dietary Supplements and Functional Foods by Liquid Chromatography Catharina Y.W. Ang, Yanyan Cui, Hebron C. Chang, WenhongLuo, Thomas M. Heinze, Lawrence J. Lin, and Antonia Mattia, U.S. Food and Drug Administration, National Center for Toxicological Research, Division of Chemistry, HFT-230, 3900, NCTR Rd, Jefferson, AR 72079,, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, Division of Petition Review, HFS-265, 5100 Paint Branch Pkwy, College Park, MD 20740 The method presents results dealing with the extraction and the determination of four (4) bioactive St. John’s wort compounds (pseudohypericin (PHP), hypericin (HP), hyperforin (HF), and adhyperforin (AHF)) in SJW aerial parts (leaves and flowers), dietary supplements and functional foods such as SJW capsules, tea bag, snack bar, puff and drinks. The compounds were well separated through the developed HPLC method using an isocratic elution program. The starting material was sonicated in a methanolic solution and the obtained extract was analyzed through LC/UV at 2 wavelengths (290 & 590 nm) and LC/MS analysis. Two standard calibration curves with high and lowlevel ranges were constructed for the quantitative determination of target compounds using BKF as an internal standard. P ROS /S TRENGTHS : This method has good separation and detection techniques such as HPLC, UV, and MS allowing the separation and quantitative analysis of individual SJW bioactive compounds. This method could be applied to several matrixes. C ONS /W EAKNESSES : No internal standard was used for hypericin, pseudohypericin, and some samples (Snack bar). Confirmation by LC/ESI/MS should be performed using the same chromatographic conditions. The retention time changes due to the column and room temperature variation and also to the used mobile phase pH variation. Recovery test should be performed on blank matrixes. Author(s): S UMMARY OF M ETHOD : G ENERAL C OMMENTS :

EXPERT REVIEW PANEL VOTE AND RECOMMENDATION

MOTION: Not to make a decision on this method regarding First Action Official Method status pending review of results validation data for method suitability for hyperforin determination. (Brown, Sharaf – Unanimous) Amended: This method is not recommended for First Action official Method status based on the data presented. (Brown, Sharaf – Unanimous) Motion Passed

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