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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.
No suitability requirements. A biological control material was used.
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.
No, the control was not used for quantitative methods and there were no system suitability
requirements
4.
Based on the supporting information, is the method written clearly and concisely? If no, please
specify the needed revisions.
Yes. It is clear and concise (maybe too concise)
5.
Based on the supporting information, what are pros/strengths of the method?
Good chromatography, a nice range of samples were tested
6.
Based on the supporting information, what are cons/weaknesses of the method?
An internal standard would help. Also, it was not fully validated for both alkaloids
7.
Any general comments about the method?
The method would be greatly improved with the use of a labeled internal standard. Also, the
lack of information about the 7-OH alkaloid needs to be addressed
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.
Not at this time, if further information supporting the analytical range, LOQ, LOD, recovery,
RSDr, and RSDR is added for both analytes of interest, then I would consider it (although the
spike recovery is out of range and would likely be improved by the use of labeled internal
standards)