Candidates for 2016 ERP of the Year

Primary and Secondary Evaluation of Method SJW-16

SJW-16:

St. John’s wort

Author(s):

USP32–NF27 Page 1066

UMMARY OF

ETHOD

ENERAL

OMMENTS

This is an HPLC method for total hypericins and hyperforin at 270nm using a response factor based on

oxybenzone. This is a general method for identity and quality control, but lacks any detail around the

actual validation data. This method uses an external calibrant without calibration curves or calibrant of

the same structure as the analytes of interest. The mobile phase also uses a three phase mobile phase

and long separation time, both of which are undesirable for routine laboratory analysis. The actual

hypericin and hyperforin standards are not used; instead a response factor is used based on

oxybenzone. The sample preparation states minimal light exposure and use of low-actinic glassware.

This is the USP monograph for St. Johns Wort, including botanical identification, qualitative and

quantitative tests. The content of hypericin, pseudohypericin and hyperforin are quantified by extracting

1 gram of dried aerials with 50 mL acetone: methanol (1:1 v/v) at 60C for 2 hours. The extract was

separated with C18 column (250 x 4.6 mm) in 66 minutes. Quantitation is performed using oxybenzone

and response factors.

ROS

TRENGTHS

This method analyzes three (3) analytes of interest in the SMPR.

ONS

EAKNESSES

This method lacked detail, used one point calibration curve with response factors, and used three (3)

solution mobile phases. The 66 minute separation is too long for routine analysis. Quantitation is not

done with reference standards of the identical analytes. No chromatograms were provided. There is

also no information on measuring at 588 nm in the experimental section.

EXPERT REVIEW PANEL VOTE

AND

RECOMMENDATION

MOTION: Not to consider this method for First Action Official Method status.

Mudge, Schaneberg (Unanimous) Motion Passed

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