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Chem, Res. Center Crete, IL – Report of A Validation of LC-MS/MS Method for Folate Analys
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satisfactory in all of the studied SPIFAN matrices at investigated spike levels.
The results of the spike recovery evaluation were calculate in a form which provides a comprehensive
evaluation of the total folate spike recovery in the SPIFAN II samples. The results are presented in the
following Table 22. Averages of per cent spike recovery of total folate in replicates of all the samples
calculated irrespective of their spike level.
Table 22: % Spike recovery of total folate in samples spiked with targeted folate irrespective of
the level of the spike
Sample#
Sample
Lot#
Spike of
individual
folates
compounds
as folic acid
Spike of total
folate
calculated as
folic acid
Average %
Spike
Recovery of
total folate
(n=9)
% RSD 0f the
total folate
spike
recovery
replicates
(n=9)
mcg/100g
1
Child Formula
Powder
00411RF00
REC'D
12/4/15
10-80
60-500
100.3
2.7
2
Infant
Elemental
Powder
00402RF00
REC'D
12/4/15
10-70
60-500
98.7
1.3
3
Adlt Nutritional
RTF, High
Protein
00821RF00
REC'D
12/4/15
10-70
60-500
94.4
2.2
4
Adult
Nutritional RTF,
High Fat
00820RF00
REC'D
12/4/15
10-70
60-500
95.6
3.2
5
Infant Formula
RTF Milk Based
(SPIFAN Blank
Milk Form)
EV4H2Q
REC'D
12/4/15
10-70
60-500
107.7
3.4
All
Average of All Samples , all
spike levels (n=45)
Varied
Varied
99.3
5.4
The SPIFAN samples were spiked with each targeted folate compound (with each of seven targeted
compounds at three different spike levels) and total spike level as folic acid calculated as sum of
concentration of all folate compounds as folic acid. Average % spike recovery of total folate in SPIFAN
II samples is provided in the above Table. % spike recovery of total folic acid in the samples was
found to be in the range of 94 to 108%. All of the spiked SPIFAN samples provided a spike recovery
within the recovery range 90-110% stipulated by the SMPR. Folate recovery analysis was satisfactory
in all of the studied SPIFAN matrices.
The repeatability of % spike recovery analysis in multiple replicates of the SPIFAN samples evaluated
as % RSD value. These were found to be in the range of from 1.3 % to 3.4 %. The repeatability of
2011.06/Fol-22 (February 2016)
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