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The method should be validated for precision, LOD and LOQ.
2.
Does the method contain system suitability tests or controls as specified by the SMPR? If no,
please indicate if there is a need for such tests or controls and which ones.
Yes.
3.
Is there information demonstrating that the method system suitability tests and controls as
specified in the SMPR worked appropriately and as expected? If no, please specify.
Yes.
4.
Based on the supporting information, is the method written clearly and concisely? If no, please
specify the needed revisions.
The information including preparation of standard solution, spiking, calibration curve, and
precision is missing from this method.
5.
Based on the supporting information, what are pros/strengths of the method?
This method can identify multi alkaloids in Mitragyna speciosa and related samples, and is
useful for the quantitative determination of mytragynine and 7-hydroxymitragynine.
6.
Based on the supporting information, what are cons/weaknesses of the method?
This method is not completely validated.
7.
Any general comments about the method?
The developed method is suitable for the analysis of mitragynine and 7-hydroxymitragynine in
Mitragyna speciosa and related products.
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.
This method should be further validated.