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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