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Silliker
Chem, Res. Center Crete, IL – Report of A Validation of LC-MS/MS Method for Folate Analysis
40
2
Adult Nutritional Powder Milk Protein
Based
11750017V3
POWDER
9
4.42
3
Infant Formula Powder Partially
Hydrolyzed Milk Based
1172572116
POWDER
9
13.54
4
Infant Formula Powder Partially
Hydrolyzed Soy Based
117257651Z
POWDER
9
12.56
5
Adult Nutritional Powder Low Fat
00394RF00
POWDER
9
4.38
6
Child Formual Powder
00412RF00
POWDER
9
5.91
7
Infant Elemental Powder
00403RF00
POWDER
9
2.92
8
Infant Formula Powder Milk Based
D04HTCVV
POWDER
9
6.35
9
Infant Formula Powder Soy Based
E29JVLV
POWDER
9
6.56
10
Infant Formula RTF Milk Based
SPIFAN CONTROL
MILK FORM
LIQUID
9
6.65
11
Adult Nutritional RTF High Protein
00414RF00
LIQUID
9
3.68
12
Adult Nutritional RTF High Fat
00406RF00
LIQUID
9
2.82
* Minor Includes = 5-CHO-THF + THF + 10-CH3-FA + 10-CHO-FA + Methenyl-THF
Conclusions:
1.
A LC-MS/MS method was developed and validated for analysis of different folate
vitamers.
2.
HPLC conditions and mass spec parameters were optimized.
3.
The composition of extraction buffer and analysis buffer were adjusted to provide
best analytical response of the analytes.
4.
SPE conditions and elution solvents were selected to provide best recovery of the
analytes.
5.
The method accuracy was evaluated and established by analysis of various
reference materials.
6.
The method employed to analyzed a series of the SPIFA samples. The powder
samples were reconstituted to the liquid form and RTF samples were analyzed as
is. The results expresse as mcg/100g of total folate as folic acid (sum of the
detected folate compounds after calculation as folic acid)
7.
The method precision was evaluated for folate analysis in the SPIFAN samples
and was found satisfactory.
8.
Results of selected folate vitamers are presented for certain reference material.
9.
Five SPIFAN samples (two powders and three RTF) were spiked with targeted
folate compounds at three different levels (spike Level I, II and III). % spike
recovery of folates as folic acids ranged from 92 to 104%. All the spiked samples
provided spike recovery within the recovery range 90-110% stipulated by the
SMPR. Folate recovery analysis was satisfactory in all of the studied SPIFAN
matrices.
2011.06 (Fol-22) w/SLV
FOR ERP USE ONLY
DO NOT DISTRIBUTE