AOAC SPDS Set 2 ERP

Method Review Form

AOAC INTERNATIONAL Standards Development

Name of Reviewer: Nour Eddine ES-SAFI Title of Method: Quantification of Mitragynine in Kratom Raw Materials and Finished Products by High-Performance Liquid Chromatography: Singly Laboratory Validation

AOAC Candidate Method Number : KRA-02 Applicable SMPR: AOAC SMPR 2015.008

I. SUMMARY OF METHOD The method entitled "Quantification of Mitragynine in Kratom Raw Materials and Finished Products by High-Performance Liquid Chromatography: Singly Laboratory Validation" presents results dealing with the quantitative analysis of mitragynine in 8 matrixes including dried leaves, extract, capsule and beverages which were purchased from commercial vendors. The method used separation through an analytical HPLC with detection at 226 nm. Example of the obtained results showed the separation of various compounds with this method. The quantitative analysis of mitragynine in the studied samples was determined after calibration using a commercial mitragynine sample. II. REVIEW OF THE METHOD ONLY: 1. Does the applicability of the method support the applicability of the SMPR? If no, please explain what is missing. The applicability of the method does not support the applicability of the SMPR. Thus, the AOAC SMPR 2015.008 stated that “the Methods must be able to quantitate mitragynine, 7- hydroxymitragynine, and separate other relevant indole alkaloids of Mitragyna speciosa , in a broad range of matrices, including plant material, extracts, and finished products”. The proposed KRA-02 method was tested on various different samples including dried leaves, extract, capsule and beverages. However, only mitragynine was quantified in the studied samples while the quantitative analysis of other analytes such as 7-hydroxymitragynine was not done The authors indicated that the content of 7-hydroxymitragynine was below the quantitation limit for all the explored samples, therefore this method is only valid for the detection and quantitation of mitragynine in raw materials, bulk extracts and finished products.

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