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December 2010


References 1 ICH Q8 (R2) – Guidance for Industry, Pharmaceutical Development, 2009


2 L.R. Snyder and J.L. Glajch, Computer-assisted Method Development for High Performance Liquid Chromatography, Elsevier, Amsterdam, 1990 (also J. Chromatogr. 485 (1989) 1-682).


3 I. Molnar, J. Chromatogr. A. 965 (2002) 175.


4 T.H. Hoang, D. Cuerrier, S. McClintock, M. Di Maso, J. Chromatogr. A. 991 (2003) 281.


5 H.W. Bilke, I. Molnar, Ch. Gernet, J. Chromatogr. A 729 (1996)189.


6 R. Bonfichi, J. Chromatogr. A 678 (1994) 213. 7 L. Wrisely, J. Chromatogr. 628 (1993) 191. 8 H. Hofmann, I. Molnar, Pharm. Ztg. Wiss. 1 (1992) 137.


9 P.A. Ryan, B.A. Ewels, J.L. Glajch, J. Chromatogr. 550 (1991) 549.


10 R.G. Lehman, J.R. Miller, J. Chromatogr. 485 (1989) 581. 11 J. Fulper, J. Chromatogr. 485 (1989) 579.


12 R.C. Chloupek, W. Hancock, B.A. Marchylo, J.J. Kirkland, B. Boyes, L.R. Snyder, J. Chromatogr. A 686 (1994) 45.


13 A.J.J.M. Coenen, L.H.G. Henckens, Y. Mengerink, S van der Wal, P.J.L.M. Quaedifleig, L.H. Koole, E.M. Meijer, J. Chromatogr. 596 (1992) 59.


Figure 10. Experimental (a) and predicted (b) chromatograms obtained using the following chromatographic conditions - tG : 45


min, T: 50°C and eluent B: (80:20)(MeOH:AN V/V) (green circle depicted in Fig.7). Doxepin isomers are shown in the predicted chromatogram (Rt = 31.014 and 31.509 min). The peak at 2.25 min in Fig 10a corresponds to the maleate counterion.


14 H. Fritsch, I. Molnar, M. Wurl, J. Chromatogr. A 684 (1994) 65. 15 A.H. Schmidt, I. Molnar, J. Chromatogr. A. 948 (2002) 51.


16 L. Van Heukelem, C. S. Thomas, J. Chromatogr. A. 910 (2001) 31.


17 M.L. Hajnos, M. Waksmundzka-Hajnos, K. Glowniak, Acta Chromatographica 12 (2002) 211.


18 W. Markowski, K.L. Czapinska, Chem. Anal. (Warsaw) 42 (1997) 353.


19 W. Metzger, K. Reif, J. Chromatogr., A. 740 (1996) 133.


20 T.H. Dzido, E. Soczewinski, J. Gudej, J. Chromatogr. 550 (1991) 71.


21 T-Y. Liu, A. Robbat, Jr., J. Chromatogr. 539 (1991) 1.


22 W. Markowski, T.H. Dzido, E. Soczewinski, J. Chromatogr. A 523 (1990) 81.


23 D.J. Thompson, W.D. Ellenson, J. Chromatogr. 485 (1989) 607.


24 I. Molnar, LC•GC Europe (2001) 231.


25 J. A. Lewis, L. R. Snyder, J. W. Dolan, J. Chromatogr. A 721 (1996) 15.


26 R. Dappen, I. Molnar, J. Chromatogr. A 592 (1992) 133. 27 L.R. Snyder, J. Chromatogr. B 689 (1997) 105.


28 I. Molnár, H-J. Rieger, K.E. Monks, J. Chromatogr. A 1217 (2010) 3193.


29 M. R. Euerby, F. Scannapieco, H-J. Rieger, I. Molnar, J Chromatogr. A 1121 (2006) 219.


30 J. W. Dolan, L.R. Snyder, N.M. Djordjevic, D.W. Hill, D.L. Saunders, L. Van Heukelem, T.J. Waeghe, J. Chromatogr. A 803 (1998) 1.


Figure 11. Experimental (a) and predicted (b) chromatograms obtained using the following chromatographic conditions - tG


31 Sz. Fekete, J. Fekete, I. Molnár, K. Ganzler, J. Chromatogr. A, 1216 (2009) 7816.


: 22 min, T: 55°C and eluent B: 100% MeOH (dark blue circle depicted in Fig.7). Doxepin isomers are shown in the predicted chromatogram (Rt = 18.913 and 19.223 min). The peak at 2.25 min in Fig 11a corresponds to the maleate counterion.


32 Sz. Fekete, J. Fekete, K. Ganzler, J. Pharm. and Biomed. Anal. 49 (2009) 833.


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