ID:
501332
Duration (hours):
56
CFU:
6
SSD:
CHIMICA FARMACEUTICA
Year:
2025
Overview
Date/time interval
Secondo Semestre (02/03/2026 - 19/06/2026)
Syllabus
Course Objectives
At the end of the course the student will be trained on theoretical, applicative and practical aspects of the instrumental techniques and methodologies commonly used in the pharmaceutical industry for the analysis of actives in pharmaceutical dosage forms and biological matrices. The three complementary aspects will favour the student capabilities in setting up an analytical method.
Course Prerequisites
To successfully follow the course and attend the related laboratory practicals, it is essential that students have knowledge of inorganic and organic chemistry, molecules of pharmaceutical interest, spectroscopy and chromatography.
An anonymous, self-assessed entry test will help students understand whether they meet the prerequisites. See also below "Learning assessment methods".
An anonymous, self-assessed entry test will help students understand whether they meet the prerequisites. See also below "Learning assessment methods".
Teaching Methods
The course is organised in four complementary sections: 1. Lectures on theoretical basis of instrumental techniques for pharmaceutical analysis; 2. Searching, reading and discussion of peer-reviewed scientific papers related to applications of the instrumental techniques; 3. Dry lab: bibliographic search, introduction to wet lab, videos; 4. Wet lab: HPLC (qualitative and quantitative analysis of an active substance of pharmaceutical interest, calibration curve). CE (qualitative and quantitative analysis of an active substance of pharmaceutical interest). At the end of wet lab practicals each student will have to write a Final Report of the activities. For students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Methods, teaching material suitable for profitable independent study will be available. If requested, self-learning can be supported by tutoring activities of supplementary teaching, and by dedicated meetings, also online, with flexible hours depending on needs.
Assessment Methods
Two tests are envisaged, one at a very early stage of the course (to verify knowledge of prerequisites) and one just before the end of the semester. They are open to all students upon registration, they are not assessed and are intended to be used by the student for a self-test of his/her level of comprehension/preparation. The first is strongly suggested to ALL attendants, the second is suggested to students who intend to sit the exam befor the end of July
The final exam is oral, to better evaluate whether the student is able to critically integrate and discuss the theoretical, applicative and practical aspects of the use of instrumental techniques for pharmaceutical analysis. Besides the oral exam, also the wet lab practicals and the quality of the Final Report will contribute to the final assessment. Appropriate examination methods are foreseen for students who fall into the categories foreseen for Specific Learning Disorders (DSA) and Special Educational Needs (BES).
The final exam is oral, to better evaluate whether the student is able to critically integrate and discuss the theoretical, applicative and practical aspects of the use of instrumental techniques for pharmaceutical analysis. Besides the oral exam, also the wet lab practicals and the quality of the Final Report will contribute to the final assessment. Appropriate examination methods are foreseen for students who fall into the categories foreseen for Specific Learning Disorders (DSA) and Special Educational Needs (BES).
Texts
Cavrini V., Andrisano V., PRINCIPI DI ANALISI FARMACEUTICA 3a ed., Esculapio;
Skoog, Holler, Nieman, PRINCIPLES OF INSTRUMENTAL ANALYSIS, Harcourt Brace;
Saini G., Mentasti E, FONDAMENTI DI CHIMICA ANALITICA (analisi chimica strumentale), UTET;
Snyder L.R., PRACTICAL HPLC METHOD DEVELOPMENT, Wiley;
Ahuja, S. Jimidar MI, CAPILLARY ELECTROPHORESIS METHODS FOR PHARMACEUTICAL ANALYSIS, Academic Press;
Pawliszyn J., Lord H.L., HANDBOOK OF SAMPLE PREPARATION, Wiley;Eric S. Grumbach;
Joseph C. Arsenault; Douglas R. McCabe: Beginners Guide to UPLC: Ultra-Performance Liquid Chromatography, 1st Ed., Waters Corporation, 2009; Michael W Dong: HPLC and UHPLC for practicing Scientists, 2nd Ed., Wiley, 2019.
Skoog, Holler, Nieman, PRINCIPLES OF INSTRUMENTAL ANALYSIS, Harcourt Brace;
Saini G., Mentasti E, FONDAMENTI DI CHIMICA ANALITICA (analisi chimica strumentale), UTET;
Snyder L.R., PRACTICAL HPLC METHOD DEVELOPMENT, Wiley;
Ahuja, S. Jimidar MI, CAPILLARY ELECTROPHORESIS METHODS FOR PHARMACEUTICAL ANALYSIS, Academic Press;
Pawliszyn J., Lord H.L., HANDBOOK OF SAMPLE PREPARATION, Wiley;Eric S. Grumbach;
Joseph C. Arsenault; Douglas R. McCabe: Beginners Guide to UPLC: Ultra-Performance Liquid Chromatography, 1st Ed., Waters Corporation, 2009; Michael W Dong: HPLC and UHPLC for practicing Scientists, 2nd Ed., Wiley, 2019.
Contents
Sample preparation (LLE, SPE); stationary phases for LC (theory and applications); validation and development of analytical methods according to ICH Guidelines Q2(R2) and Q14; chiral LC stationary phases (theory and applications); supercritical fluid chromatography and supercritical fluid extraction (theory and applications); capillary electrophoresis, CE (theory and applications); UPLC (theory and applications); micro e nano HPLC (theory and applications). Reading and discussion during class of peer-reviewed scientific papers selected by the lecturer and related to some of the topics above mentioned.
Course Language
Italian
More information
The course is English friendly. Slides are in English, ICH guidelines downloaded from the EMA site are in English, research papers read in class are in English.
Degrees
Degrees
MEDICINAL CHEMISTRY AND PHARMACEUTICAL TECHNOLOGY
Single-cycle Master’s Degree
5 years
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