AOAC SPIFAN Nutrients ERP (December 7, 2022)

Amino-07 (SLV) 10-2022 FOR ERP USE ONLY DO NOT DISTRIBUTE

Summary A hydrophilic interaction liquid chromatography-tandem mass spectrometry (HILIC-MS/MS) method for the determination of taurine in infant formula and adult nutritionals was evaluated by single laboratory validation. The data obtained provides verification that the method is fit for-purpose and meets the requirements of SMPR 2014.013 (Table 1; Appendix A). • A wide range of nutritional and infant formula types were used for this study. • The linear calibration range (0.27–2700 mg hg − 1 RTF) evaluated exceeds the requirements specified in the SMPR (0.5–2500 mg hg − 1 RTF). • Repeatability (1.6–6.4 % RSD r ) measured was consistent with expected values compared to the Horwitz ratio. • Acceptable repeatability (4.5, 1.8, and 1.8 % RSD r ) compared to limits specified in the SMPR was demonstrated. • The estimated limit of quantitation (0.14 mg hg − 1 ) is lower than trequired in the SMPR. • Recovery (97.2–100.1 %) measured was consistent with expected values at ~10 mg hg − 1 concentration. • Acceptable recovery (99.2–101.4 %) compared to limits specified in the SMPR was demonstrated. • No bias found for reference values of NIST certified reference materials. • No bias found for results compared AOAC Official Method 997.05. • The robustness of method was demonstrated with a Plackett-Burman trial. • Selectivity of method assured by use of chromatographic separation, multiple reaction monitoring, and comparing ion ratios in sample to pure standards.

Table 1: Validation results compared to SMPR 2014.013 criteria SMPR parameter Criteria

Results

analytical range limit of quantitation

0.5–2500 mg hg − 1 RTF 0.27–2700 mg hg − 1 RTF

≤ 0.5 mg hg − 1 RTF ±12 % (88–112 %) ±10 % (90–110 %) ±7 % (93–107%)

0.14 mg hg − 1 RTF

recovery

0.5–50 mg hg − 1 RTF 5–150 mg hg − 1 RTF 150–2500 mg hg − 1 RTF 0.5–50 mg hg − 1 RTF 5–150 mg hg − 1 RTF 150–2500 mg hg − 1 RTF 0.5–50 mg hg − 1 RTF 5–150 mg hg − 1 RTF 150–2500 mg hg − 1 RTF

99.2 % 102.3 % 101.4 %

repeatability

≤ 7 ≤ 5 ≤ 3

4.5 % 1.8 % 1.8 %

not required for first action

reproducibility

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