SPDS Lutein and Turmeric ERPs

General Information

Reviewer Name:

Hong You

Email:

hongyou@eurofinsus.com

Organization:

Method Reviewed:

LUT‐02

Method Title:

Determination of Lutein and Zeaxanthin Esters and Their Geometric Isomers in  Carotenoid Ester Concentrates Used as Ingredients in Nutritional Supplements:  Validation of a Combined Spectrophotometric‐HPLC Method

Applicable SMPR

2016.004

I.  Summary

Summary of Method:

The combined spectrophotometric‐LC method was published in August 2016 at J  AOAC and submitted to the ERP for SPDS Set 4 Ingredients in response to the call for  methods. A three‐step procedure is used, involving (1) an HPLC chromatogram of the  saponified sample to calculate the composite‐specific absorbance value based on its  carotenoid profile and documented or estimated extinction coefficients (1%) of  predominant geometrical isomers of lutein and zeaxanthin esters, (2) measurement  of the optical absorbance of the unsaponified sample and calculation of its specific  absorbance at 445 nm, and (3) calculation of the total carotenoid ester content of  the sample. No calibration standards are needed for this protocol.

1.  Does the Applicability of the  Method Support the Applicability  of the SMPR?  If not, please explain  what is missing. II.  Review of the Method Only 2.  Does the analytical technique(s)  used in the method meet the  SMPR?  If not, please specify how it  differs from what is stated in the  SMPR. 3.  Are the definitions specified in  the SMPR used and applied  appropriatly in the method?  If no,  please indicate how the terms are  used. 4.  Does the method, as written,  contain all appropriate precautions  and warnings related to the  method's regaents, components,  instrumentation, or method steps  that may be hazardous?  If no,  please suggest wording or  option(s). 1.  Are the definitions specified in  the SMPR used and applied  appropriately in the supporting  documentation (manuscripts,  method studies, etc…)?  If not,  please explain the differences and  if the method is impacted by the  difference.  

This method is able to separately determine the fatty acid esters of the cis and trans  isomers of lutein and zeaxanthin in ingredients and dietary supplements. However, it  cannot distinguish the esterified and nonesterified forms of these xanthophylls. In  addition, this method did not document any information about beta‐cryptoxanthin.

Yes, the analytical techniques used in the method meet the SMPR requirements.

Authors used “Precision” as the term to document both “Repeatability” and  “Reproducibility” procedures.  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. Method's reagents, components, instrumentation, or method steps are generally  safe.

III.  Review of Information in Support of the Method

Yes.