Primary and Secondary Evaluation of Method SJW-11
SJW-11:
Determination of hyperforin in St. John’s wort Extract and Plant Material by High-
performance Liquid Chromatography (INA Method 112.001)
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 hyperforin content in St. John’s wort. The sample
preparation involves sonication and centrifugation prior to analysis. The method is a fairly typical HPLC
method; however, it does not include any validation data. The majority of well equipped analytical labs
could run this assay.
P
ROS
/S
TRENGTHS
:
This is a simple and straightforward HPLC method that most analytical labs would have the analytical
equipment needed to run this method.
C
ONS
/W
EAKNESSES
:
The Hyperforin in the solution is not stable. This method does not include any validation data.
EXPERT REVIEW PANEL VOTE
AND
RECOMMENDATION
MOTION:Not to consider this method for First Action Official Method status.
Reif, Schaneberg (Unanimous) Motion Passed
ERP PROFILE SUMMARIES
93