Liquid chromatography-tandem mass spectrometry determination of N-nitrosamines released from rubber or elastomer teats and soothers.
A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method as an alternative to a gas chromatography-thermal energy analyser (GC-TEA) method recommended by the European Committee on Standardization (CEN) was validated for the simultaneous determination of eight N-nitrosamines released into artificial saliva from rubber or elastomer teats and soothers. N-nitroso-dipropylamine-d₁₄ (NDPA-d₁₄) was used as internal standard for accurate quantification. The method was validated with relatively good analytical results, including sufficiently low limits of detection (0.1-2 µg kg⁻¹) of sample) and good linearity (r²> 0.99) throughout the studied concentration ranges. Intra- and inter-day precisions expressed with the relative standard deviation (RSD, %) were 3.4-8.0% and 4.4-11.3%, which were below the performance criteria based on one-half of the value derived from the Horwitz value. It was also found that the LC-MS/MS method is sufficiently rugged and successfully applicable to its routine analysis for the compliance test of Commission Directive 93/11/EEC.
National Institute of Food and Drug Safety Evaluation, Eungpyung-gu, Seoul, Korea.
J H
JH
Sung
I S
IS
Kwak
S K
SK
Park
H I
HI
Kim
H S
HS
Lim
H J
HJ
Park
S H
SH
Kim
D001903:Bottle Feeding / Q000009:adverse effects / Q000295:instrumentation*; D002273:Carcinogens / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D003257:Consumer Product Safety; D020724:Elastomers / Q000737:chemistry*; D006801:Humans; D007223:Infant; D057230:Limit of Detection; D008954:Models, Biological; D009602:Nitrosamines / Q000032:analysis* / Q000737:chemistry; D041361:Pacifiers / Q000009:adverse effects; D015203:Reproducibility of Results; D056910:Republic of Korea; D012408:Rubber / Q000737:chemistry*; D012463:Saliva / Q000737:chemistry*; D021241:Spectrometry, Mass, Electrospray Ionization; D053719:Tandem Mass Spectrometry
D002273:Carcinogens; D020724:Elastomers; D009602:Nitrosamines; D012408:Rubber