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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
Author(s):
Institute for Nutraceutical Advancement Methods Validation Program
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).
EXPERT REVIEW PANEL VOTE
AND
RECOMMENDATION
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
ERP PROFILE SUMMARIES
92