Recognizing paracetamol formulations with the same synthesis pathway based on their trace-enriched chromatographic impurity profiles

Analytica Chimica Acta

Volumn 655, Issue 1-2, 2009, Pages 43-51

  Dumarey, M ^a   van Nederkassel, A M ^a   Stanimirova, I ^a,b   Daszykowski, M ^a,b   Bensaid, F ^c   Lees, M ^c   Martin, G J ^c   Desmurs, J R ^d   Smeyers Verbeke, J ^a   Vander Heyden, Y ^a  

^a VRIJE UNIVERSITEIT BRUSSEL   (Belgium)

^b UNIVERSITY OF SILESIA   (Poland)

^c Eurofins Medinet Inc   (Germany)

^d Espace G2C   (France)

Author keywords

Chemometric exploration; Impurity profiling; Paracetamol; Synthesis pathway; Trace enrichment chromatography

Indexed keywords

CHEMOMETRICES; IMPURITY PROFILING; PARACETAMOL; SYNTHESIS PATHWAY; SYNTHESIS PATHWAYS;

CHROMATOGRAPHIC ANALYSIS; CHROMATOGRAPHY; CLUSTER ANALYSIS; DRUG PRODUCTS PLANTS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HIGH PRESSURE LIQUID CHROMATOGRAPHY; IMPURITIES; PRINCIPAL COMPONENT ANALYSIS; PROFITABILITY; REGRESSION ANALYSIS; SYNTHESIS (CHEMICAL);

DRUG PRODUCTS;

PARACETAMOL; REAGENT; SOLVENT;

ARTICLE; CATALYST; CHEMOMETRIC ANALYSIS; CLUSTER ANALYSIS; CONTROLLED STUDY; DRUG FORMULATION; DRUG IMPURITY; DRUG MANUFACTURE; DRUG SYNTHESIS; FORGERY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRINCIPAL COMPONENT ANALYSIS; PRIORITY JOURNAL;

ACETAMINOPHEN; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CLUSTER ANALYSIS; DOSAGE FORMS; DRUG CONTAMINATION; MULTIVARIATE ANALYSIS; PRINCIPAL COMPONENT ANALYSIS;

EID: 71749099586     PISSN: 00032670     EISSN: 18734324     Source Type: Journal    
DOI: 10.1016/j.aca.2009.09.050     Document Type: Article

References (20)

1. Hersh E.V., Moore P., and Ross G.L. Clin. Ther. 31 (2000) 500
2. Eccles R. J. Clin. Pharm. Ther. 31 (2006) 309
3. European Medicines Agency, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use, http://www.emea.europa.eu/pdfs/human/pmf/2001-83-EC.pdf (accessed on the 2nd of April 2009).
4. Deconinck E., van Nederkassel A.M., Stanimirova I., Daszykowski M., Bensaid F., Lees M., Martin G.J., Desmurs J.R., Smeyers-Verbeke J., and Vander Heyden Y. J. Pharmaceut. Biomed. 48 (2008) 27
5. Komatsu T., and Hirose T. Appl. Catal. A: Gen. 276 (2004) 95
6. Rode C.V., Vaidya M.J., Jaganathan R., and Chaudhari R.V. Chem. Eng. Sci. 56 (2001) 1299
7. Ellis F. Paracetamol-A Curriculum Resource (2002), Royal Society of Chemistry, Cambridge p. 8
8. Padró C.L., and Apesteguía C.R. J. Catal. 226 (2004) 308
9. Ahuja S. Impurities Evaluation of Pharmaceuticals (1998), Marcel Dekker, New York p. 59
10. International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use, ICH harmonised tripartite guideline: impurities in new drug substances Q3A(R2), step 4 (2006), http://www.ich.org/LOB/media/MEDIA422.pdf (accessed on the 15th of May 2008).
11. van Nederkassel A.M., Xu C.J., Lancelin P., Sarraf M., MacKenzie D.A., Walton N.J., Bensaid F., Lees M., Martin G.J., Desmurs J.R., Massart D.L., Smeyers-Verbeke J., and Vander Heyden Y. J. Chromatogr. A 1120 (2006) 291
12. Daszykowski M., Walczak B., and Massart D.L. Chemometr. Intell. Lab. 65 (2003) 97
13. Bishop C.M., Svensen M., and Williams C.K.I. Neural Comput. 10 (1998) 215
14. Massart D.L., and Kaufman L. In: Elving P.J., Winefordner J.D., and Kolthoff I.M. (Eds). The Interpretation of Analytical Chemical Data by the Use of Cluster Analysis (1983), John Wiley & Sons, New York 75
15. Vandeginste B.G.M., Massart D.L., Buydens L.M.C., De Jong S., Lewi P.J., and Smeyers-Verbeke J. Handbook of Chemometrics and Qualimetrics: Part B (1998), Elsevier, Amsterdam p. 69
16. Questier F., Put R., Coomans D., Walczak B., and Vander Heyden Y. Chemometr. Intell. Lab. 76 (2005) 45
17. Smyth C., Coomans D., Everingham Y., and Hancock T. Chemometr. Intell. Lab. 80 (2006) 120
18. Breiman L., Friedman J.H., Olshen R.A., and Stone C.J. Classification and Regression Trees (1984), Wadsworth, Monterey, CA, USA
19. De'ath G. Ecology 83 (2002) 1105
20. Nielsen N.P.V., Carstensen J.M., and Smedsgaard J. J. Chromatogr. A 805 (1998) 17