It is difficult, if not impossible, to visualize pharmaceutical industry processes without appropriate analytical control, of which chromatographic and, more recently, capillary electromigration techniques constitute a considerable proportion. Problems such as deciding which separation technique will be the best, whether a chromatographic or an electrokinetically driven method is preferred, calibration procedures and method validation, identification of impurities by on-line hyphenation with techniques based on physicochemical principles other than chromatography and electrophoresis and assaying of basic physicochemical properties are all to be solved by the analytical chemist. Unintended errors can occur quite frequently. This volume covers all pharmaceutical research which is seen to cause problems in practice. The basic guidelines have been summarized along with the necessary theoretical background to help analysts select and apply modern chromatographic and electrokinetic methods of analysis in drug production and quality control and help them solve their particular problems.

Table of Contents:
Quality control methods for synthetic drugs. Comparison of separation and non-separation technologies (X.-Z. Qin). Considerations for the development of separation methods for pharmaceutical quality control (B.A. Olsen, P.K.S. Tsang). High performance liquid chromatographic monitoring of process impurities in bulk drugs and formulations (S. Husain, R. Nageswara Rao). Regression and calibration for analytical separation techniques. Part I: Design considerations (K. Baumann, H. Watzig). Regression and calibration for analytical separation techniques. Part II: Validation, weighted and robust regression (K. Baumann). Pharmaceutical applications of liquid chromatography, capillary electrophoresis coupled to mass spectrometry (M. Hamdam). Lipophilicity estimation of drugs (G.L. Biagi et al. ). Determination of dissociation constants by separation methods (HPLC and CE). Theoretical background and guidelines for application (M. Uhrovai et al. ). Potential of capillary electrophoresis with micelles or chiral additives as a purity control method in pharmaceutical industry (M.-L. Riekkola, S.K. Wiedmer). Analytical methods for peptide drugs applicable to process control (M. Castagnolai et al. ). Assessment of protein drugs obtained by recombinant DNA technology (R.E. Kaiser et al. ). Ion-pairing procedures applicable to drug quality control (A.K. Dash).