Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

Primary and Secondary Evaluation of Method SJW-01

SJW-01:

Hypericumperforatum-Chemical Profling and Quantitative Results of St. John’s wort Products by an Improved High-Performance Liquid Chromatography Method M. Ganzera, J. Zhao, I.A. Khan, National Center for Natural Products Research, Research Institute of Pharmaceutical Sciences, The University of Mississippi, University, Mississippi 38677, Department of Pharmacognosy, School of Pharmacy, The University of Mississippi, University, Mississippi 38677

Author(s):

S UMMARY OF M ETHOD : G ENERAL C OMMENTS :

The method is a fairly typical HPLC method used to quantify nine (9) main Hypericumperforatum compounds in 35 minutes. The indicated compounds are hypericin, hyperforin, pseudohypericin, and six (6) flavonoids: rutin, hyperoside, isoquercitrin, quercitrin, quercetin and 3, II8-Biapigenin. The identity of each of the compounds was confirmed in an LC-MS experiment. The sample preparation for this method involves methanol extraction (4 times), centrifugation and filtration. P ROS /S TRENGTHS : The method is simple and straightforward HPLC method and sample preparation. It was noted that the manuscript has method validation data and the majority of well equipped analytical labs could run this assay. The laboratory used five (5) commercially available standards and isolated three (3). At least two of these standards, hypericin and hyperforin, are commercially available from Addipharma in Germany. The I3, II8-biapigenin was quantified utilizing a relative response factor (according to literature and relative to rutin). C ONS /W EAKNESSES : The manuscript does not contain detail regarding the types of samples tested (i.e., matrices not well defined). The manuscript refers to commercial samples but does not give details of the type of samples.

EXPERT REVIEW PANEL VOTE AND RECOMMENDATION

MOTION:Not to make a decision on the method at this time pending review of the SLV data. Roman, Brown (Unanimous) – Motion Passed

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