Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

Primary and Secondary Evaluation of Method SJW-10

SJW-10:

Determination of hypericin and pseudohypericin in St. John’s wort by high- performance liquid chromatography

Institute for Nutraceutical Advancement Methods Validation Program

Author(s):

S UMMARY OF M ETHOD : G ENERAL C OMMENTS :

This is a HPLC/UV method used to test the hypericin and pseudophypericin content in St. John’s wort. The powdered extract sample preparation involves sonication, centrifugation, and a light exposure conversion step prior to analysis. The herb sample preparation is a reflux, rotary evaporator concentration, dilution step and a light exposure conversion step prior to analysis. P ROS /S TRENGTHS : Simple and straightforward HPLC method. Most analytical labs would have the analytical equipment needed to run this method. C ONS /W EAKNESSES : The plant material (herb) sample preparation is time consuming (reflux, rotovap, light conversion). MOTION: Adopt this method as First Action Official Method status for the analytes (hypericin and pseudohypericin) and matrices (plant material and powdered extracts) specified by the method and supported by the validation report. Roman, Sharaf (Unanimous) Motion Passed MOTION: Requirements for Final Action Official Method status: 1. Optimize method with consideration given to sample preparation for plant material, additional matrices, and column technology. • Changes to the method may require additional performance data to ensure the method meets the AOAC SMPR 2013.001. 2. Statistically significant reproducibility data will be required to consider this method for final action.  Use of Certified Reference Material to acquire PT data, or  Full collaborative study (minimum of 6 blind duplicates, 8 laboratories) Schaneberg, Brown (Unanimous) Motion Passed EXPERT REVIEW PANEL VOTE AND RECOMMENDATION

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