SPDS Lutein and Turmeric ERPs

Authors did not use the reference materials recommended by the SMPR.

2.  Is there information  demonstrating that the method  meets the SMPR Method  Performance Requirements using  the Reference Materials stated in  the SMPR?   If not,  then specify  what is missing and how this  impacts demonstration of  performance of the method.   3.  Is there information  demonstrating that the method  performs within the SMPR Method  Preformance Requiements table  specifications for all analytes in the  SMPR applicability statement?  If  not, please specify what is missing  and whether or not the method's  applicaiblity should be modified.   1.  Based on the supporting  information, were there any  additional steps in the evaluation  of the method that indicated the  need for any addional  precautionary statements in the  method? 2.  Does the method contain  system suitability tests or controls  as specified by the SMPR?  If not,  please indicate if there is a need  for such tests or controls, and  which ones. 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. 4.  Based on the supporting  information, is the method written  clearly and concisely?  If no, please  specify the needed revisions. 5.  Based on the supporting  information, what are the  pros/strenghts of the method? IV.  General Submission Package

Analytical range: Submitted method has its analytical range between approximately  0.1 to 100%. The SMPR requires 0.0005 to 100%. LOQ: Method did not document LOQ. Recovery: For samples that have their range >1%, the submitted method has 97% as  its recovery, while the SMPR requires recovery as 98‐102%. Note: the definition of  recovery is different between the submitted method and SMPR. Authors established  “Recovery” by comparing the analytical results of commercial samples with values  from suppliers’ Certificate of Analysis, while the SMPR requires comparing the  analytical results from spiked sample with their theoretical value.  

Repeatbility: Submitted method has its repeatability RSDr 

Yes. Authors may need to admit that the extinction coefficients in table 1 are not  precisely applicable to this method because they were established at their λmax not  445 nm.

Yes. The method contains system suitability tests.

Yes.

Yes.

The method is easy to conduct and does not require calibration standards for the  routine quantification. The method has high accuracy for the determination of total  xanthophyll ester contents. Also, the method is robust when cis‐isomers of lutein  and zeaxanthin are present in a significant amount. The method cannot distinguish the esterified and nonesterified forms of  xanthophylls. In addition, this method did not document any information about beta‐ cryptoxanthin.

6.  Based on the supporting  information, what are the cons  /weaknesses of the method?