A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603)

Journal of Pharmaceutical and Biomedical Analysis

Volumn 46, Issue 3, 2008, Pages 431-441

  Gavin, Peter F ^a   Olsen, Bernard A ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Atomoxetine; Column equivalence; In situ degradation; Ion pairing; Liquid chromatography; Quality by design; System suitability

Indexed keywords

ATOMOXETINE; MANDELIC ACID; PHENYLMETHYLAMINOPROPANOL; PROPANOLAMINE DERIVATIVE; UNCLASSIFIED DRUG;

ANALYTIC METHOD; ARTICLE; DEVICE; DRUG IMPURITY; DRUG PURITY; DRUG QUALITY; DRUG STRUCTURE; ELUTION; EVALUATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; ION PAIR CHROMATOGRAPHY; PARAMETER; PRIORITY JOURNAL; PROCESS OPTIMIZATION; QUALITY BY DESIGN; QUALITY CONTROL;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; PROPYLAMINES;

EID: 37749005415     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2007.10.037     Document Type: Article

References (22)

1. Pharmaceutical cGMPS for the 21st Century-A risk-based approach, Final report, Department of Health and Human Services, U.S. Food and Drug Administration, September 2004.
2. International Conference on Harmonization Tripartite Guideline "Q8: Pharmaceutical Development" Nov 10, 2005, 1-8.
3. Chromatography in the United States Pharmacopeia, USP 30-NF 25, The USP Convention, Inc., Rockville, MD, 2007 (Chapter 621).
4. Sellers J.A., Olsen B.A., Owens P.K., and Gavin P.F. J. Pharm. Biomed. Anal. 41 (2006) 1088-1094
5. Gavin P.F., Olsen B.A., Wirth D.D., and Lorenz K.T. J. Pharm. Biomed. Anal. 41 (2006) 1251-1259
6. Görög S. Anal. Bioanal. Chem. 377 (2003) 852-862
7. In: Görög S. (Ed). Identification and Determination of Impurities in Drugs (2000), Elsevier, Amsterdam 1-22
8. Olsen B.A., and Baertschi S.W. Strategies for investigation and control of process and degradation-related impurities. In: Ahuja S., and Alsante K.M. (Eds). Handbook of Isolation and Characterization of Impurities in Pharmaceuticals (2003), Academic Press, San Diego pp. 89-117
9. Wirth D.D., Olsen B.A., Hallenbeck D.K., Lake M.E., Gregg S.E., and Perry F.M. Chromatographia 46 (1997) 511-523
10. Meyer V.R. Pitfalls and Errors of HPLC in Pictures (1997), Hüthig Hiedelberg pp. 56-57
11. United States Pharmacopeia, USP 30-NF 25, The USP Convention, Inc., Rockville, MD 2007, p. 2165.
12. European Pharmacopeia. 5th ed. (2007), Council of Europe, Strasbourg p. 1104
13. Olsen B.A., and Argentine M.A. J. Liq. Chromatogr. Relat. Technol. 19 (1996) 1993-2007
14. Snyder L.R., Maule A., Heebsh A., Cuellar R., Paulson S., Carrano J., Wrisley L., Chan C.C., Pearson N., Dolan J.W., and Gilroy J.J. J. Chromatogr. A 1057 (2004) 49-57
15. Dolan J.W., Maule A., Bingley D., Wrisley L., Chan C.C., Angod M., Lunte C., Krisko R., Winston J.M., Homeier B.A., McCalley D.V., and Snyder L.R. J. Chromatogr. A 1057 (2004) 59-74
16. Visky D., Vander Heyden Y., Iványi T., Baten P., De Beer J., Kovács Z., Noszál B., Roets E., Massart D.L., and Hoogmartens J. J. Chromatogr. A 977 (2002) 39-58
17. Visky D., Vander Heyden Y., Iványi T., Baten P., De Beer J., Kovács Z., Noszál B., Dehouck P., Roets E., Massart D.L., and Hoogmartens J. J. Chromatogr. A 1012 (2003) 11-29
18. Visky D., Haghedooren E., Dehouck P., Kovács Z., K'oczían K., Noszál B., Hoogmartens J., and Adams E. J. Chromatogr. A 1101 (2006) 103-114
19. Olsen B.A., Castle B.C., and Myers D.P. Trends Anal. Chem. 25 (2006) 796-804
20. Chromatography-System Suitability in: United States Pharmacopeia, USP 30-NF 25, The USP Convention, Inc., Rockville, MD, 2007 (Chapter 621).
21. United States Pharmacopeia, USP 30-NF 25, The USP Convention, Inc., Rockville, MD, 2007, p. 2866.
22. United States Pharmacopeia, USP 30-NF 25, The USP Convention, Inc., Rockville, MD, 2007, p. 3493.