Primary and Secondary Evaluation of Method SJW-12
SJW-12:
Determination of naphthodiantrones in St. John’s wort extracts and herbal drugs
(SOP No. DC-185)
Author(s):
Euromed USA
S
UMMARY OF
M
ETHOD
:
G
ENERAL
C
OMMENTS
:
This is a spectrophotometric method for the determination of hypericins in St. John's wort extracts and
herbal plant preparations. The method concerns qualitative determination of hypericins through
spectrometry analysis at 590 nm. Extraction method is straight forward and allows for exposure time
under white light prior to analysis. White light is used to ensure conversion to protohypericin to
hypericin. A blank is always run with each sample and samples are prepared in duplicate. Although the
method is simple and straight forward, it only looks at the total hypericins without actual separation of
the individual compounds. As this is a nonspecific method, it would not give good information on the
individual compounds for use in a clinical research program. It would be beneficial possibly in a QC
program internally of raw material verification.
P
ROS
/S
TRENGTHS
:
This method is simple and easy to follow and is good for internal quality controls.
C
ONS
/W
EAKNESSES
:
The use of hypericin specific absorption which could vary according to the operating conditions.The
presence of other compounds absorbing in the used 590 nm range could conduct to erroneous results.
As a nonspecific method, it does not quantify for the individual hypericin compounds. As 590nm is based
on color analysis, the method would unlikely detect adulteration.
EXPERT REVIEW PANEL VOTE
AND
RECOMMENDATION
MOTION: Not to consider this method for First Action Official Method status.
Es-Safi, Schaneberg (Unanimous) Motion Passed
ERP PROFILE SUMMARIES
94