The course, intended to provide theoretical and practical knowledge on instrumental techniques used for the determination of the purity of a drug, for the qualitative detection and for the determination of the amount of the active ingredients in a more or less complex systems, for the determination of the stability of a drug and for checks aimed at the search and identification of metabolites.

Control of the quality of analytical methods.

Recalls of chemical-physical properties of molecules of pharmaceutical interest: acidity and basicity, distribution coefficient, stability and stereochemistry.

UV/visible spectroscopy - Instrumentation and sample preparation. Qualitative analysis: correlation UV spectrum and chemical structure. Quantitative analysis: Lambert-Beer law, pKa determination and other applications of interest in quantitative pharmaceutical analysis.

Infrared Spectroscopy - Instrumentation, sample preparation, identification of polymorphs and other applications of pharmaceutical interest. Near infrared spectroscopy (NIR): principles and applications.

Differential Scanning Calorimerty (DSC): principles and and applications in pharmaceutical analysis.

Molecular Emission Spectroscopy - Fluorescence spectroscopy: principles, instrumentation applications of pharmaceutical interest.

Mass spectrometry - Ionization sources: EI, CI, FAB, ESI, APCI and MALDI. Analyzers: magnetic sector, single and triple quadrupole, ion trap, time of flight and Orbitrap. High resolution mass spectrometry. Tandem mass spectrometry. Applications to pharmaceutical and biological sciences.

Chromatographic techniques - Gaschromatography: columns, injectors and detectors (FID, thermal conductivity, electron capture and mass); parameters that regulate the performance of GC and applications of GC in analysis of pharmaceutical interest. HPLC: instrumetation, mobile and stationary phases, parameters that regulate the performance of HPLC and applications of the instrumental technique in analysis of pharmaceutical interest. Ultra-Performance Liquid Chromatography (UPLC). TLC: quantitative analytical applications. 

Qualitative analysis and quantitative techniques in chromatography.

Polarimetric analysis: instrumentation and applications in pharmaceutical and food fields.

High performance capillary electrophoresis: key points, instrumentation and applications.

Extraction methods in pharmaceutical analysis, solid-phase extraction (SPE) and  solid-phase microextraction (SPME).

Practical exercises focus on the analysis of herbal, food, nutraceutical and pharmaceutical preparations.

In order to attend the laboratory practice and acquire the frequency signature, it is necessary to have passed the exam of Organic Chemistry I and attended the laboratory practice of Drug Analysis II.

In order to take the exam it is necessary to acquire the signature of attendance and have passed the examinations of Organic Chemistry I, Drug Analysis I and Drug Analysis II.

 D1 - Knowledge and understanding. The student should have acquired the  theoretical and practical knowledge on instrumental techniques used for the determination of the purity of a drug, for the qualitative detection and for the determination of the amount of the active ingredients in a more or less complex systems, for the determination of the stability of a drug and for checks aimed at the search and identification od metabolites. 

D2 - Applying knowledge and understanding. The student will be able to apply the knowledge acquired during the course, and then be able to conduct qualitative and quantitative instrumental analysis of substances of pharmaceutical interest in more or less complex systems obtaining valid results. The student must also be able to plan and implement an analytical method. 

D3 - Making judgements. The student must be able to interpret the experimental data and the results obtained. These skills will be verified through targeted oral application questions.

D4 - Communication skills. After completing the course the student will be able to present what he has learned using appropriate terminology for the purpose of scientific communication regarding methodologies and issues concerning the analysis of compounds of pharmaceutical interest. The student will be able to organize and present clear and complete reports.

D5 - Learning skills. The student will have developed the learn ability useful to continuously update his knowledge and will be able to use it in order to face new analytical issues.

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

Teaching

Lectures (3 cfu) and laboratory (3 cfu) practice.

Attendance

Attendance at laboratory practice is compulsory in order to acquire the attendance signature and be able to take the exam.

Course books

D. G. Watson Pharmaceutical Analysis, 3rd Edition, Elsevier. 

Assessment

Upon approval of the practical part of the lab, the assessment of learning provides for an oral exam (lasting 30-40 min)  to verify the student's acquisition of the theoretical concepts and the practical procedures carried out during laboratory exercises. Knowledge of instrumental techniques used in determining the purity of drugs, qualitative identification and quantitative dosing of active principles in more or less complex systems, drug stability controls, and metabolic research and identification will be required for the student. It will also be verified the student's ability to link the topics covered during lessons as well as solve practical and application issues.The oral examination is expressed in thirties.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.