HPLC in Pharmaceutical Analysis

Part 1 Theoretical and practical aspects of HPLC separations: summary of important chromatographic parameters; characterization of separation methods on the basis of possible interactions of the analyses with the mobile and stationary phases; the separation column; detection. Part 2 Gradient elution: selection of gradient conditions; gradient volume concept; use of gradient elution to optimize solvent strength for corresponding isocratic separations; some practical aspects of gradient elution. Part 3 Derivative formation in HPLC: post-column derivation. Part 4 Separation methods based on secondary chemical equilibria: methods based on ion-suppression; methods based on metal-chelate formation; ion-pair chromotography; normal phase ion-pair chromotography; inclusion complex formation chromotography. Part 5 Optimization of HPLC methods used in pharmaceutical analysis - methods development: most important considerations for initial separations; optimization of the separation system; solvent selectivity - iso-elutropic mobile phases; methods applicable for phase system optimization; peak purity assessment; expert systems for optimization; system optimization. Part 6 Quantitative analysis - method validation: general aspects; quantitive analysis; method validation; revalidation. Part 7 Separation problems in pharmaceutical analysis: most important analytical tasks in pharmaceutical analysis; selection of most applicable separation system; application of HPLC methods in the pharmaceutical analysis; application of HPLC in drug design; application of HPLC in drug development; application of HPLC in the analysis of the production of drug substances; application of HPLC in the analysis of formulations; analysis of drugs and metabolites in biological fluids; problems associated with stability testing; chiral separations; role of the HPLC methods in different pharmacopoeias and in the registration of pharmaceutical products - present requirements and future trends.