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The method does not contain the method performance requirements stated in the AOAC SMPR
2015.008 single laboratory requirements. As stated earlier, the method is qualitative but the
requirements are for a quantitative method. The method can be modified to include a
calibration curve and the requirements in table 1 could be meet. One significant drawback is
the ability of other laboratories to perform the method due to the requirement of a QTof or
Orbitap. If a laboratory could demonstrate the separation, maybe the method could be
transferred to a PDA.
7.
Any general comments about the method?
Overall, this method addresses the main issue of analytical separation and identification of 7-
hydroxy mitragynine, mitragynine, and 11 other indole alkaloids. If quantitation is important for
the SMPR 2015.008, the method can be modified.
V.
RECOMMENDATION FOR THE METHOD:
1.
Do you recommend this method be adopted as a First Action and published in the
Official
Methods of Analysis of AOAC INTERNATIONAL?
If no, please specify rationale.
I would overall recommend this method with the few comments I have mentioned in the above
sections. Per the AOAC SMPR 2015.008, Table 1method performance requirements, the
method would require some additional analysis to determine the analytical range , LOD, LOQ,
recovery, and repeatability.