Use of evaporative light scattering detection for the quality control of drug substances: Influence of different liquid chromatographic and evaporative light scattering detector parameters on the appearance of spike peaks

Journal of Chromatography A

Volumn 1217, Issue 14, 2010, Pages 2163-2170

  Almeling, Stefan ^a   Holzgrabe, Ulrike ^b  

^a European Directorate for the Quality of Medicines and Health Care   (France)

^b UNIVERSITY OF WÜRZBURG   (Germany)

Author keywords

Evaporative light scattering detection (ELSD); Impurities control; Pharmaceutical analysis; Spike peaks

Indexed keywords

DRUG SUBSTANCES; ELUENTS; EVAPORATION TEMPERATURE; EVAPORATIVE LIGHT SCATTERING DETECTION; EVAPORATIVE LIGHT SCATTERING DETECTION (ELSD); EVAPORATIVE LIGHT SCATTERING DETECTORS; GAS FLOWS; IMPURITY PROFILE; LOW LEVEL; ORGANIC MODIFIER; PHARMACEUTICAL ANALYSIS; SPIKE PEAKS; TEST SOLUTIONS; UV DETECTION;

AERODYNAMICS; CHROMATOGRAPHIC ANALYSIS; CUSTOMER SATISFACTION; DETECTORS; FLOW OF GASES; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IMPURITIES; LIGHT SCATTERING; LIQUIDS; REFRACTION; SCATTERING; TOTAL QUALITY MANAGEMENT;

QUALITY CONTROL;

DRUG; ORGANIC COMPOUND;

ANALYTICAL EQUIPMENT; ANALYTICAL PARAMETERS; ARTICLE; CHEMICAL COMPOSITION; CHROMATOPHORE; CONCENTRATION (PARAMETERS); DRUG IMPURITY; DRUG QUALITY; EVAPORATION; FLOW RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; QUALITY CONTROL; TEMPERATURE; ULTRAVIOLET RADIATION;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; FLOW INJECTION ANALYSIS; LIGHT; NEBULIZERS AND VAPORIZERS; PHARMACEUTICAL PREPARATIONS; SCATTERING, RADIATION; SENSITIVITY AND SPECIFICITY; TEMPERATURE;

EID: 77949262333     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chroma.2010.02.017     Document Type: Article

References (26)

1. Guideline Q3A(R2), Impurities in New Drug Substances, International Conference on Harmonisation 2006, http://www.ich.org.
2. European Pharmaocopeia, 6th ed., Counsil of Europe, Strasbourg, 2007.
3. Douville V., Lodi A., Miller J., Nicolas A., Clarot I., Prilleux B., Megoulas N., and Koupparis M. Pharmeur. Sci. Notes 1 (2006) 9
4. Lantz D., Risley D.S., and Peterson J.A. J. Liq. Chromatogr. Rel. Technol. 20 (1997) 1409
5. Kohler M., Haerdi W., Christen P., and Veuthey J.L. Trends Anal. Chem. 16 (1997) 475
6. Ying L., and Chang-Qin H. Chromatographia 57 (2003) 143
7. Manyanga V., Grishina O., Yun Z., Hoogmartens J., and Adams E. J. Pharm. Biomed. Anal. 45 (2007) 257
8. Nair V.D.P., Kanfer I., Hoogmartens J., and Adams E. J. Pharm. Biomed. Anal. 41 (2006) 731
9. Clarot I., Chaimbault P., Hasdenteufel F., Netter P., and Nicolas A. J. Chromatogr. A 1031 (2004) 281
10. Lodi A., Mercier I., Prilleux B., Streissel P., and Thietard L. Pharmeur. Sci. Notes 1 (2007) 39
11. Petritis K., Elfakir C., and Dreux M. J. Chromatogr. A 961 (2002) 9
12. S. Kopec, PhD thesis, University of Würzburg, http://www.opus-bayern.de/uni-wuerzburg/volltexte/2008/2641/.
13. Charlesworth J.M. Anal. Chem. 50 (1978) 1414
14. Young C.S., and Dolan J.W. LC-GC Eur. 3 (2003) 192
15. Robinson J.L., Tsimidou M., and Macrae R. J. Chromatogr. 324 (1985) 35
16. Asmus P.A., and Landis J.B. J. Chromatogr. 316 (1984) 461
17. Mathews B.T., Higginson P.D., Lyons R., Mitchell J.C., Sach N.W., Snowden M.J., Taylor M.R., and Wright A.G. Chromatographia 60 (2004) 625
18. Van der Meeren P., Vanderdeelen J., and Baert L. Anal. Chem. 64 (1995) 1056
19. Cobb Z., Shaw P.N., Lloyd L.L., Wrench N., and Barrett D.A. J. Microcol. Sep. 13 (2001) 169
20. Deschamps F.S., Baillet A., and Chaminade P. Analyst 127 (2002) 35
21. Guiochon G., Moysan A., and Holley C. J. Liq. Chromatogr. 11 (1988) 2547
22. Stolyhwo A., Colin H., Martin M., and Guiochon G. J. Chromatogr. 228 (1984) 253
23. Oppenheimer L.E., and Mourey T.H. J. Chromatogr. 323 (1985) 297
24. Mourey T.H., and Opppenheimer L.E. Anal. Chem. 56 (1984) 2427
25. Stolyhwo A., Colin H., and Guiochon G. J. Chromatogr. 265 (1983) 1
26. Alexander J.N. J. Microcol. Sep. 10 (1998) 491