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

[1]  B. Olsen,et al.  HPLC Method Development for Duloxetine Hydrochloride Using a Combination of Computer-Based Solvent Strength Optimization and Solvent Selectivity Mixture Design , 1996 .

[2]  Veronika R. Meyer,et al.  Pitfalls and errors of HPLC in pictures , 1997 .

[3]  Screening methods for impurities in multi-sourced fluoxetine hydrochloride drug substances and formulations , 1997 .

[4]  S. Görög.  Identification and determination of impurities in drugs , 2000 .

[5]  Y. Heyden,et al.  Characterisation of reversed-phase liquid chromatographic columns by chromatographic tests. Evaluation of 36 test parameters: repeatability, reproducibility and correlation. , 2002, Journal of chromatography. A.

[6]  Zsuzsanna Kovács,et al.  Characterisation of reversed-phase liquid chromatographic columns by chromatographic tests. Rational column classification by a minimal number of column test parameters. , 2003, Journal of chromatography. A.

[7]  Karen M. Alsante,et al.  Handbook of Isolation and Characterization of Impurities in Pharmaceuticals , 2003 .

[8]  S. Görög.  Chemical and analytical characterization of related organic impurities in drugs , 2003, Analytical and bioanalytical chemistry.

[9]  J. Winston,et al.  Choosing an equivalent replacement column for a reversed-phase liquid chromatographic assay procedure. , 2004, Journal of chromatography. A.

[10]  S. Baertschi,et al.  Strategies for investigation and control of process- and degradation-related impurities , 2004 .

[11]  L. Snyder,et al.  A fast, convenient and rugged procedure for characterizing the selectivity of alkyl-silica columns. , 2004, Journal of chromatography. A.

[12]  P. F. Gavin,et al.  A quality evaluation strategy for multi-sourced active pharmaceutical ingredient (API) starting materials. , 2006, Journal of pharmaceutical and biomedical analysis.

[13]  B. Olsen,et al.  Advances in HPLC technology for the determination of drug impurities , 2006 .

[14]  J. Hoogmartens,et al.  Facilitated column selection in pharmaceutical analyses using a simple column classification system. , 2006, Journal of chromatography. A.

[15]  P. K. Owens,et al.  Determination of the enantiomer and positional isomer impurities in atomoxetine hydrochloride with liquid chromatography using polysaccharide chiral stationary phases. , 2006, Journal of pharmaceutical and biomedical analysis.