Validation of thin layer and high performance thin layer chromatographic methods

Journal of Chromatography A

Volumn 1218, Issue 19, 2011, Pages 2712-2721

  Renger, B ^a   Vegh Z ^b   Ferenczi Fodor, K ^b  

^a Bernd Renger Consulting   (Germany)

^b GEDEON RICHTER LTD   (Hungary)

Author keywords

HPTLC; TLC; Uncertainty; Validation

Indexed keywords

ANALYTES; ANALYTICAL PERFORMANCE; ANALYTICAL VALIDATION; CHROMATOGRAPHIC METHODS; CHROMATOGRAPHIC PROCEDURE; COMPLEX MATRICES; CONTROL CHARTS; HPTLC; QUANTITATIVE ASSAY; ROBUSTNESS TESTING; SCREENING TESTS; THIN LAYERS; TLC; UNCERTAINTY; VALIDATION;

CHROMATOGRAPHIC ANALYSIS; QUALITY ASSURANCE;

CHROMATOGRAPHY;

SORBENT;

ACCURACY; ANALYTICAL PARAMETERS; ARTICLE; ENVIRONMENTAL FACTOR; HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; PRIORITY JOURNAL; QUALITY CONTROL; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; SAMPLING; SOLVENT EXTRACTION; STANDARDIZATION; THIN LAYER CHROMATOGRAPHY; VALIDATION PROCESS;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, THIN LAYER; REPRODUCIBILITY OF RESULTS; SPECTROMETRY, MASS, ELECTROSPRAY IONIZATION;

EQUUS ASINUS;

EID: 79954633056     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chroma.2011.01.059     Document Type: Article

References (42)

1. EURACHEM: the fitness for purposes of analytical methods. A laboratory guide to method validation and related topics. http://www.eurachem.org/guides/pdf/valid.pdf, 1998.
2. ICH harmonised tripartite guideline: validation of analytical procedures: text and methodology, Q2 (R1), Geneva. http://www.ich.org/LOB/media/MEDIA417.pdf, 2005 (Parent Guideline dated 27 October 1994, Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005).
3. Draft guidance analytical procedures and method validation. US Food and Drug Administration, Centre for Drugs and Biologics, Department of Health and Human Services. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122858.pdf, August 2000.
4. CDER reviewer guidance: validation of chromatographic methods, US Food and Drug Administration, Centre for Drugs and Biologics, Department of Health and Human Services. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM134409.pdf, November 1994.
5. United States Pharmacopeia 33, First Supplement to the USP-NF Reissue, General Chapter <1225>, Validation of Compendial Methods, US Pharmacopoeial Convention, Rockville, MD, April, 2010, R-660.
6. Ermer J., Miller J.H.McB. Method Validation in Pharmaceutical Analysis. A Guide to Best Practice 2000, Wiley-VCH Verlag GmbH & Co, KGaA, Weinheim.
7. Shabir G.A., Lough W.J., Shafique A.A., Bradshaw T.K. J. Liq. Chromatogr. Related Technol. 2007, 30:311.
8. Shabir A. J. Chromatogr. A 2003, 987:57.
9. Funk W., Damman V., Vonderheid C., Oehlmann G. Statistische Methoden in der Wasseranalytik 1985, VCH, Weinheim.
10. Funk W., Damman V., Donnevert G. Qualitätssicherung in der Analytischen Chemie 1992, VCH, Weinheim.
11. Funk W., Damman V., Donnevert G. Quality Assurance in Analytical Chemistry 1995, VCH, Weinheim.
12. Ferenczi-Fodor K., Végh Z., Pap-Sziklay Zs. J. Planar Chromatogr. 1993, 6:198.
13. Szepesi G. J. Planar Chromatogr. 1993, 6:187.
14. Renger B., Jehle H., Fischer M., Funk W. Pharm. Ind. 1994, 56:993.
15. Renger B., Jehle H., Fischer M., Funk W. J. Planar Chromatogr. 1995, 8:269.
16. Indrayanto G., Yuwono M. Encyclopedia of Chromatography 2005, 1759. Frances & Taylor LLC. 2nd ed. J. Cazes (Ed.).
17. Reich E., DeBarr A. J. AOAC Int. 2009, 91:13.
18. Ferenczi-Fodor K., Végh Z., Nagy-Turák A., Renger B., Zeller M. J. AOAC Int. 2001, 84:1265.
19. Ferenczi-Fodor K., Renger B., Végh Z. J. Planar Chromatogr. 2010, 23:173.
20. Monograph 2.01.03 Ultraviolet Ray Lamps for Analytical Purposes, European Pharmacopoeia (suppl. 6.8) 2010, European Pharmacopoeia Commission, Strasbourg, France, p. 21. 6th ed.
21. Nagy-Turák A., Végh Z., Ferenczi-Fodor K. J. Planar Chromatogr. 1995, 8:188.
22. United States Pharmacopeia 30 General Chapter <1225>, Validation of Compendial Methods 2007, US Pharmacopoeial Convention, Rockville, MD, p. 680.
23. Dejaegher B., Vander Heyden Y. J. Chromatogr. A 2007, 1158:138.
24. Dejaegher B., Vander Heyden Y. LC-GC Europe 2006, (July):418.
25. Ferenczi-Fodor K., Végh Z., Renger B. J. Chromatogr. A 2011, 1218:2722.
26. United States Pharmacopeia 32 General Chapter <466>, Ordinary Impurities 2009, US Pharmacopoeial Convention, Rockville, MD, p. 162.
27. ICH harmonised tripartite guideline: stability testing of new drug substances and products Q1A (R2), Geneva. http://www.ich.org/LOB/media/MEDIA419.pdf, 2003 (Parent Guideline dated 30 March 1995).
28. ICH harmonised tripartite guideline: impurities in new drug substances, Q3A (R1), Geneva. http://www.ich.org/LOB/media/MEDIA422.pdf, 2006 (Parent Guideline dated 16 September 1992).
29. Monograph 2.02.27 Thin-Layer Chromatography, European Pharmacopoeia (suppl. 6.8) 2010, European Pharmacopoeia Commission, Strasbourg, France, p. 43. 6th ed.
30. Ebel S. Analytical Chemistry Progress 1984, Springer, Berlin-Heidelberg, p. 71.
31. Analytical methods committee: is my calibration linear? AMC Technical Brief No. 3. http://www.rsc.org/amc, December 2000.
32. Ermer J. Method Validation in Pharmaceutical Analysis. A Guide to Best Practice 2005, 88. Wiley-VCH Verlag GmbH & Co, KGaA, Weinheim. J. Ermer, J. Miller (Eds.).
33. Loco J.V., Elskens M., Croux C., Beernaert H. Accredit. Qual. Assur. 2002, 7:281.
34. Einax J.W., Reichenbächer M. Anal. Bioanal. Chem. 2006, 384:14.
35. Guide to the Expression of Uncertainty in Measurement, ISO, Geneva, 1993. ISBN 92-67-10188-9 (Reprinted 1995).
36. Joint committee for guides in metrology: evaluation and measurement data-guide to the expression of uncertainty in measurement, vol. 100. http://www.bipm.org/utils/common/documents/jcgm/JCGM_100_2008_E.pdf, 2008.
37. S.L.R. Ellison, M. Rösslein, A. Williams (Eds.), Eurachem/CITAC Guide: Quantifying Uncertainty in Analytical Measurement, 2nd ed., 2000. http://www.eurachem.org/guides/pdf/QUAM2000-1.pdf.
38. EN ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories 2005, EN Management Centre, Brussels.
39. Meyer V.R. J. Chromatogr. A 2007, 1158:15.
40. Renger B. J. Chromatogr. B 2000, 745:167.
41. Monograph Levonorgestrel European Pharmacopoeia (suppl. 6.8) 2010, European Pharmacopoeia Commission, Strasbourg, France, p. 2266. 6th ed.
42. Massart D.L., Vandeginste B.G.M., Deming S.N., Michotte Y., Kaufman L. Chemometrics: A Textbook 1988, Elsevier, Amsterdam.