11438 - Drug Analysis II (GR.A)

Learning outcomes

The subject of the course is quantitative analysis applied in the pharmaceutical field, performed through the use of chemical, chemio-physical and physical analytical methods. It provides the theoretical and practical basis that is fundamental for the main techniques used for the measurement of drugs and medications. The course sets out to provide students with professional training in the basic theoretical notions of pharmaceutical quantitative analysis, allowing their verification and understanding in individual experimental work in the laboratory. Through the knowledge and use of various analytical methodologies, students acquire the skills, experience and manual approaches necessary for the correct solution of diverse analytical problems, such as the determination of the content or purity of an active ingredient or quality control in the pharmaceutical sector.  At the end of the course, which will include laboratory exercises in a single place, the student will possess knowledge of methods of quantitative analysis, volumetric and instrumental, reported in the monographs of the European Pharmacopoeia (Ph. Eur) and the Italian Official Pharmacopoeia (FUI) for the determination of the purity of active ingredients and the content of active ingredient in commercial formulations. In particular, the student is able to:

- apply their knowledge to real problems (unknowns quantitative analysis and quality control of pharmaceutical preparations);

- propose alternative methods of analysis with respect to those officers, rationally justifying the choices made on the basis of the foreground.

Course contents

The teaching syllabus comprises a theoretical part, which imparts a knowledge of the chemical and instrumental analytical techniques for quantitative measurement and determination of the purity of pharmaceutical substances, both as raw materials and in pharmaceutical formulations. It is followed by an applied part, during which the notions learnt are put into practice.  After an introduction to the basic aspects of applied chemical analysis in the pharmaceutical field and some remarks on the fundamental principles of quantitative analysis, the theoretic teaching deals with the chemical and instrumental methods of pharmaceutical analysis. The former include gravimetric analysis and volumetric analyses realised by precipitimetric, redox, complexometric titrations and neutralization. The latter include quantitative analyses employing polarography, amperometry, conductometry, potentiometry, spectroscopy in absorption and emission spectra.

Readings/Bibliography

It is not necessary to purchase specific texts. The teaching material is available through username and password at AMS Campus - AlmaDL - University of Bologna. For deepening, recommended texts are: 

- Skoog, D.A., West, D.M., Holler, F.J. “Chimica Analitica, una introduzione” e “Fondamenti di Chimica Analitica”, EdiSES s.r.l., 1998.

- Voghel, A. “Analisi Chimica Quantitativa”, Ed. Ambrosiana, 1999.

- Porretta, G.C. “Analisi di preparazioni farmaceutiche- Analisi quantitativa” , Vol. primo, Ed. CISU, 2000.

- Watson, D.G. “Analisi Farmaceutica”, EdiSES s.r.l., 2003.

- Printing of the lesson slides.

- Guide to laboratory exercises “Guida alle esercitazioni del corso di Analisi dei Medicinali II".

Teaching methods

The teaching consists of theoretical lessons (40 hours)  held by the responsible teacher from October to January, and  individual practical work in a chemical laboratory (48 hours ), supervised by the same teacher, distributed among 16 consecutive afternoons.

Assessment methods

The assessment of learning tends to ensure the achievement of the teaching objectives that are:

- the knowledge of chemical, physical-chemical and instrumental methods of quantitative analysis, as well as the acquisition of experience and manual dexterity required to the correct solution of the different analytical problems;

- the ability to apply the theoretical and practical knowledge acquired at the determination of the purity of pharmaceutical substances and quality control of commercial pharmaceutical formulations;

- the ability to interpret and apply the analytical methods reported in the Italian Official Pharmacopoeia and European Pharmacopoeia for the quantitative determination of compounds of pharmaceutical interest and to evaluate their percentage content.

This verification is carried out by means of laboratory practice test, organized at the end of the practical exercises in a single place, and final oral examination. The practice final test, of unlimited validity, is a prerequisite necessary to access the oral examination. Preliminary registration in the AlmaEsami list is required for the access to oral examination. The students, of which the Council of Studies Course validates the signature frequency acquired in previous career, they must pass the laboratory practice test before the oral exam.

Teaching tools

The teaching material presented in class (slides, teaching program, program and schedule of laboratory exercises) and that which is necessary to exercises in single seat (laboratory hand outs) will be made available to the student in electronic format via the Internet. Such material should be printed and brought to the lessons and the laboratory exercises.

Italian and European Official Pharmacopoeia.

To get teaching material: http://campus.unibo.it/

Username and password are reserved for students enrolled at the University of Bologna.

Links to further information

http://www.unibo.it/SitoWebDocente/default.htm?UPN=nadia.ghedini%40unibo.it

Office hours

See the website of Nadia Ghedini

See the website of Roberto Gotti