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Vitamin B12 (cyanocobalamin) in Infant Formula Adult/Pediatric Nutritional Formula by Liquid Chromatography with
Ester Campos Giménez1, Frédéric Martin1
1Nestlé Research Center, Vers-chez-les-Blanc, 1000 Lausanne 26, Switzerland.
Insights
This study validated the AOAC Official MethodSM 2014.02 for determining Vitamin B12 in infant formula. The method demonstrated acceptable repeatability and reproducibility, meeting performance requirements for reliable vitamin B12 analysis.
Area of Science:
- Analytical Chemistry
- Food Science
- Nutritional Analysis
Background:
- Accurate quantification of Vitamin B12 is crucial for infant and adult nutritional formulas.
- AOAC Official MethodSM 2014.02 was developed for Vitamin B12 determination using liquid chromatography.
- Validation of analytical methods ensures reliability and standardization in food analysis.
Purpose of the Study:
- To assess the repeatability and reproducibility of AOAC Official MethodSM 2014.02.
- To determine if the method meets the Standard Method Performance Requirement (SMPR® 2011.005) for Vitamin B12.
- To evaluate the method for potential advancement to Final Action status.
Main Methods:
- A collaborative study involving 21 laboratories across 13 countries.
- Two-part analysis: initial duplicate testing followed by blind duplicate analysis of 10 samples for qualified labs.
- Comparison of results against established Standard Method Performance Requirements (SMPR®).
Main Results:
- Repeatability relative standard deviation ranged from 1.1% to 6.5%.
- Reproducibility relative standard deviation ranged from 6.0% to 23.8%, with one matrix exceeding the 11% requirement.
- Horwitz ratio values were consistently below 2 (0.17-0.78), indicating good method performance.
Conclusions:
- The AOAC Official MethodSM 2014.02 demonstrated acceptable precision for Vitamin B12 determination in infant and adult formulas.
- The method met the SMPR® requirements, supporting its reliability.
- The AOAC Expert Review Panel recommended the method for Final Action status.
Abstract:
To determine the repeatability and reproducibility figures of the AOAC First Action Official MethodSM 2014.02 (Vitamin B12 in Infant Formula and Adult/Pediatric Formula by Liquid Chromatography with UV Detection), a collaborative study was organized. Twenty-one laboratories located in 13 different countries agreed to participate. The study was divided into two parts. During the first part, the laboratories analyzed two samples in duplicate by using the method described in the protocol. The laboratories that provided results within the expected range were qualified for part two, during which they analyzed 10 samples in blind duplicates. Eighteen laboratories managed to provide results on time for reporting. The results were compared with the Standard Method Performance Requirement (SMPR® 2011.005) established for vitamin B12. The precision results met the requirements stated in the SMPR except for one sample. Repeatability and reproducibility relative standard deviation ranged from 1.1 to 6.5% and from 6.0 to 23.8%, respectively, with only one matrix showing reproducibility values higher than the required 11%. Horwitz ratio values were all well below 2 (0.17-0.78). The AOAC Expert Review Panel (Stakeholder Panel for Infant Formula and Adult Nutritional Expert Review Panel) determined that the data presented met the SMPR and, hence, recommended the method to be granted Final Action status in September 2016.
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