Method development and validation for the determination of 2,4,6-tribromoanisole, 2,4,6-tribromophenol, 2,4,6-trichloroanisole, and 2,4,6-trichlorophenol in various drug products using stir bar sorptive extraction and gas chromatography-tandem mass spectrometry detection

Journal of Chromatography A

Volumn 1262, Issue , 2012, Pages 196-204

  Huang, Jiun Tang ^a   Alquier, Lori ^a   Kaisa, Joyce P ^a   Reed, Gail ^b   Gilmor, Timothy ^b   Vas, Gyorgy ^a  

^a Analytical Research and Development Process and Product Scientific Solutions Johnson and Johnson   (United States)

^b McNeil Laboratories Inc   (United States)

Author keywords

2,4,6 Tribromoanisole; GC MS MS; Haloanisoles; Halophenols; Stir bar sorptive extraction

Indexed keywords

2 ,4 ,6-TRIBROMOANISOLE; GC-MS/MS; HALOANISOLES; HALOPHENOLS; STIR BAR SORPTIVE EXTRACTION;

DEUTERIUM; GAS CHROMATOGRAPHY; MASS SPECTROMETRY; PACKAGING MATERIALS;

DRUG PRODUCTS;

2,4,6 TRIBROMOANISOLE; 2,4,6 TRIBROMOPHENOL; 2,4,6 TRICHLOROANISOLE; 2,4,6 TRICHLOROPHENOL; ANISOLE DERIVATIVE; PHENOL DERIVATIVE; UNCLASSIFIED DRUG; WATER;

ARTICLE; CONTROLLED STUDY; DRUG ANALYSIS; DRUG FORMULATION; EXTRACTION; LIMIT OF DETECTION; MASS FRAGMENTOGRAPHY; PACKAGING MATERIAL; PRIORITY JOURNAL; SOLID; STIR BAR SORPTIVE EXTRACTION; TABLET; VALIDATION STUDY;

ANISOLES; CHEMICAL FRACTIONATION; CHLOROPHENOLS; GAS CHROMATOGRAPHY-MASS SPECTROMETRY; LIMIT OF DETECTION; LINEAR MODELS; PHENOLS; REPRODUCIBILITY OF RESULTS; TABLETS; TANDEM MASS SPECTROMETRY;

EID: 84867198930     PISSN: 00219673     EISSN: 18733778     Source Type: Journal    
DOI: 10.1016/j.chroma.2012.09.010     Document Type: Article

References (20)

1. Jonsson S., Uusitalo T., van Bavel B., Gustafsson I.B., Lindstrom G. Determination of 2,4,6-trichloroanisole and 2,4,6-tribromoanisole on ng/L to pg/L levels in wine by solid phase microextraction and gas-chromatography-high-resolution-mass spectrometry. J. Chromatogr. A 2006, 1111:71.
2. Boutou S., Chatonnet P. Rapid head-space solid phase microextraction/gas chromatographic/mass spectrometric assay for the quantitative determination of some of the main odorants causing off-flavors in wine. J. Chromatogr. A 2007, 1141:1.
3. Sawant A. Preliminary results of a PDA task force examining the cause, prevention and management of TBA and TCA taints. 2011 PDA/FDA Pharmaceutical Supply Chain Conference, June 2011.
4. go) partition coefficients. Fresenius J. Anal. Chem. 2001, 371:598.
5. Savenhed R., Boren H., Grimwall A. Stripping analysis and chromatographic sniffing for the source identification of odorous compounds in drinking water. J. Chromatogr. A 1985, 328:219.
6. Evans T.J., Butzke C.E., Ebeler S.E. Analysis of 2,4,6-trichloroanisole in wines using solid phase microextraction coupled to gas chromatography-mass spectrometry. J. Chromatogr. A 1997, 786:293.
7. Vas Gy., Vekey K. Solid-phase microextraction: a powerful sample preparation tool prior to mass spectrometric analysis. J. Mass Spectrom. 2004, 39:233.
8. Maggia L., Zalacain A., Mazzoleni V., Alonso G.L., Salinas M.R. Comparison of stir bar sorptive extraction and solid-phase microextraction to determine halophenols and haloanisoles by gas chromatography-ion trap tandem mass spectrometry. Talanta 2008, 75:753.
9. Patil S.H., Banerjee K., Utture S.C., Fontana A.R., Altamirano J.C., Oulkar D.P., Wagh S.S., Dasgupta S., Patil S.B., Jadhav M.R., Ugare B.R., Adsule P.G., Deshmukh M.D. Development and validation of a simple analytical method for the determination of 2, 4,6-tricholoroanisole in wine by GC-MS. Food Chem. 2011, 124:1734.
10. Vestner J., Fritsch S., Rauhut D. Development of a microwave assisted extraction method for the analysis of 2,4,6-trichloroanisole in cork stoppers by SIDA-SBSE-GC-MS. Anal. Chim. Acta 2010, 660:76.
11. Frank C., David F., de Revel G. Multi residue off-flavour profiling in wine using stir bar sorptive extraction-thermal desorption-gas chromatography-mass spectrometry. J. Chromatogr. A 2010, 1236:3318.
12. Di{dotless}az A., Ventura F., Galceran Ma T. Determination of odorous mixed chloro-bromoanisoles in water by solid-phase micro-extraction and gas chromatography-mass detection. J. Chromatogr. A 2005, 1064:97.
13. NIST/EPA/NIH Mass Spectral Library, Edition, 2009.
14. 2002/657 EU Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results, 2002.
15. FDA Guidance 118 Mass, Spectrometry for Confirmation of the Identity of Animal Drug Residues, U.S. Department of Health Services, Food and Drug Administration, Center of Veterinary Medicine, May 1, 2003.
16. Rambla-Alegre M., Esteve-Romero J., Carda-Broch S. Is it really necessary to validate an analytical method or not? That is the question. J. Chromatogr. A 2012, 1232:101.
17. Ridgeway K., Lalljie S.P.D., Smith R.M. An alternative method for analysis of food taints using stir bar sorptive extraction. Anal. Chim. Acta 2010, 677:29.
18. Wells G., Prest H., Russ C.W. Why use a signal to noise as a measure of MS performance when it is often meaningless. Curr. Trends Mass Spectrom. 2011, (May):28.
19. Upper critical values of Student's t distribution with degrees of freedom. http://itl.nist.gov/div898/handbook/eda/section3/eda3672.htm.
20. ASTM E177-10 Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods.