Meeting the International Conference on Harmonisation's Guidelines on Validation of Analytical Procedures: Quantification as exemplified by a near-infrared reflectance assay of paracetamol in intact tablets

Analyst

Volumn 125, Issue 7, 2000, Pages 1341-1351

  Moffat, Anthony C ^a   Trafford, Andrew D ^a   Jee, Roger D ^a   Graham, Paul ^b  

^a UNIVERSITY OF LONDON   (United Kingdom)

^b Alnwick Research Centre   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

PARACETAMOL;

ACCURACY; ARTICLE; DRUG DETERMINATION; DRUG STRUCTURE; INFRARED SPECTROSCOPY; QUANTITATIVE ASSAY; TABLET; VALIDATION PROCESS;

EID: 0033910049     PISSN: 00032654     EISSN: None     Source Type: Journal    
DOI: 10.1039/b002672g     Document Type: Article

References (21)

1. 1 International Conference on Harmonisation, ICH Harmonised Tripartite Guideline - Text on Validation of Analytical Procedures, Fed. Regist., 1995, 60, 11260.
2. 2 International Conference on Harmonisation, ICH Harmonised Tripartite Guideline - Validation of Analytical Procedures: Methodology, Fed. Regist., 1997, 62, 27463.
3. 3 United States Pharmacopeial Convention, United States Pharmacopeia 23, US, Rockville, 1995, p. 1982.
4. 4 Pharmacopeial Forum, 1998, 24, 6582.
5. 5 M. Blanco, J. Coello, A. Eustaquio, H. Iturriaga and S. Maspoch, J. Pharm. Sci., 1999, 88, 551.
6. 6 M. Blanco, J. Coella, A. Eustaquio, H. Itturriaga and S. Maspoch, Analyst, 1999, 124, 1089.
7. 7 European Pharmacopoeia, 3rd edn., 1996, p. 43.
8. 8 Pharmacopeial Forum, 1998, 24, 6463.
9. 9 British Pharmacopoeia 1998, Volume II, HM Stationery Office, London, 1998, p. A201.
10. 10 J. Gottfries, H. Depui, M. Fransson, M. Jongeneelen, M. Josephson, F. W. Langkilde and D. T. Witte, J. Pharm. Biomed. Anal, 1996, 14, 1495.
11. 11 D. Jouan-Rimbaud, B. Walczak, D. L. Massart, I. R. Last and K. A. Prebble, Anal. Chim. Acta, 1995, 304, 285.
12. 12 D. Jouan-Rimbaud, M. S. Khots, D. L. Massart, I. R. Last and K. A. Prebble, Anal. Chim. Acta, 1995, 315, 257.
13. 13 P. Merckle and K.-A. Kovar, J. Pharm. Biomed. Anal., 1998, 17, 365.
14. 14 P. Corti, G. Ceramelli, E. Dreassi and S. Mattii, Analyst, 1999, 124, 755.
15. 15 M. Blanco, J. Coello, H. Iturriaga, S. Maspoch and C. de la Pezuela, Talanta, 1993, 40, 1671.
16. 16 E. Dreassi, G. Ceramelli, L. Savini, P. Corti, P. L. Perruccio and S. Lonardi, Analyst, 1995, 120, 319.
17. 17 E. Dreassi, G. Ceramelli, P. Corti, P. L. Perruccio and S. Lonardi, Analyst, 1996, 121, 219.
18. 18 M. Blanco, J. Coello, H. Iturriaga, S. Maspoch and C. de la Pezuela, Analyst, 1997, 122, 761.
19. 19 M. Blanco, J. Coello, H. Iturriaga, S. Maspoch, C. de la Pezuela and E. Russo, Anal. Chim. Acta, 1994, 298, 183.
20. 20 M. Blanco, J. Coello, H. Iturriaga, S. Maspoch and C. de la Pezuela, Anal. Chim. Acta, 1996, 333, 147.
21. 21 M. Blanco, J. Coello, H. Iturriaga, S. Maspoch and D. Serrano, Analyst, 1998, 123, 2307.