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The method should be further validated for the recovery.
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.
Yes.
5.
Based on the supporting information, what are pros/strengths of the method?
The developed GC and LC methods are suitable for the analysis of mitragynine in Mitragyna
speciosa and related products. The LC method is partial validated.
6.
Based on the supporting information, what are cons/weaknesses of the method?
The LC method is partial validated. Validation of parameters including recovery, LOD and LOQ
should be included.
7.
Any general comments about the method?
The developed GC and LC methods are suitable for the analysis of mitragynine 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.