Candidates for 2016 ERP of the Year

ERP PROFILE SUMMARIES

Primary and Secondary Evaluation of Method SJW-16

SJW-16:

St. John’s wort

USP32–NF27 Page 1066

Author(s):

S UMMARY OF M ETHOD : G ENERAL C 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.

P ROS /S TRENGTHS : This method analyzes three (3) analytes of interest in the SMPR.

C ONS /W 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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