ANALISI DEI FARMACI E DEI PRODOTTI PER LA SALUTE 3 A - L

Academic Year 2025/2026 - Teacher: SIMONE RONSISVALLE

Expected Learning Outcomes

Knowledge and Ability to Understand: the student shall acquire the theoretical and practical background for the recognition of organic compounds of pharmaceutical interest reported in the monographs of official pharmacopoeias, by means of instrumental analytical techniques and chemical recognition tests.

The student should also acquire the theoretical basis of the main analytical techniques for the analysis of active ingredients in biological matrices.

Ability to apply knowledge and understanding: the student should be able to use the knowledge acquired in the field of pharmaceutical analysis to develop and validate analytical protocols on active ingredients in pharmaceutical forms and biological matrices. 

Autonomy of judgment: The student should be able to interpret the experimental results obtained related to the analysis of active ingredients present in pharmaceutical forms and complex matrices.

Communication skills: At the end of the course, the student should be able to expound what has been learned using appropriate terminology for proper scientific presentation regarding analytical techniques and analysis of compounds of pharmaceutical interest. 

Learning skills. The student should have developed theoretical/practical skills useful for being able to update and expand their knowledge in order to address new analytical problems.

Course Structure

Lectures and laboratory exercises.

If the teaching is given in a blended or distance learning mode, necessary variations from what has been stated above may be introduced in order to comply with the planned syllabus stated in the syllabus.

Required Prerequisites

The basic knowledge required for successful and easy access to the course covers General and Inorganic Chemistry, Organic Chemistry (propaedeutic), Physics, Drug and Health Product Analysis 1 and 2.

Attendance of Lessons

Mandatory

Detailed Course Content

Introduction to instrumental analytical methods. Classification of instrumental analytical methods. Choice of analytical method. Ultraviolet and visible spectroscopy in absorption and emission (fluorescence and phosphorescence). Infrared absorption spectroscopy. Mass spectrometry. Nuclear magnetic resonance spectrometry (1H- and 13C-NMR). 

Recognition of functional groups and physical-chemical constants.

Chromatographic techniques and applications. General principles of chromatographic process and chromatographic parameters: distribution constant, retention time. capacity factor. Resolution. Selectivity. Efficiency: plate theory; van Deemter equation. Chromatographic peak asymmetry.

Liquid chromatography: stationary phase, mobile phase. Liquid-solid chromatography, liquid-liquid chromatography, ion-exchange chromatography, ion-pair chromatography, molecular exclusion chromatography, affinity chromatography. Column chromatography, thin layer chromatography (TLC). High performance liquid chromatography (HPLC): instrumentation. Enantioselective chromatographic separation: direct method using enantioselective stationary phases.

Gas chromatography (GC): instrumental aspects, types of stationary phase, GC detection. Capillary Electrophoresis (EC): instrumentation, theoretical principles, analytical parameters. 

Mass spectrometry and applications: classes of instrumentation, ionization techniques, fragmentation analysis, Analyzers and detector. Combined techniques: liquid chromatography and UV-VIS photodiode detector (HPLC-DAD), liquid chromatography and mass spectrometry (HPLC-MS), gas chromatography and mass spectrometry (GC-MS).

Qualitative and quantitative analysis (external standard method, internal standard method). Sample preparation and extraction methods. Classical extraction methods (liquid/liquid and liquid/solid). Supercritical fluid extraction (SFE). Solid-phase extraction (SPE). Sample preparation from complex biological matrices. 

Analytical method validation: linearity, precision, accuracy, reproducibility, limit of detection (LOD), limit of quantification (LOQ). Development of chromatographic methods for quality control and in pre-clinical and clinical research. Determination of drug/target protein interactions, using high-performance affinity chromatography, for new drug development.

Textbook Information

  1. R.M. Silverstein, F.X. Webster, Identificazione spettroscopica di composti organici - Ambrosiana Editrice, Milano, 2016
  2. V. Cavrini. Principi di Analisi Farmaceutica, ultima edizione. Società Editrice Esculapio, Bologna
  3. J.F. Holler, S.R. Crouch. Fondamenti di chimica analitica di Skoog e West. EdiSES, III edizione 2015
  4. Veronika R. Meyer. Practical High-Performance Liquid Chromatography, 5th Edition. Wiley, New York


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Learning Assessment

Learning Assessment Procedures

Verification of learning will be by final written examination.

Verification of learning may also be conducted electronically, should conditions require it.

Information for students with disabilities and/or DSA 

To ensure equal opportunity and in compliance with current laws, interested students may request a personal interview so that any compensatory and/or dispensatory measures can be planned, based on the educational objectives and specific needs. It is also possible to contact the CInAP (Center for Active and Participatory Integration - Services for Disabilities and/or DSAs) contact person in the DSFS.

Examples of frequently asked questions and / or exercises

Theoretical principles of chromatographic separations: approaches to improve resolution in liquid chromatography. Theoretical principles and applications of capillary electrophoresis. Sample preparation and extraction methods. Validation of analytical method. Describe the chemical recognition of amines of pharmaceutical interest. Describe the mass spectrometer scheme.