The course aims to provide theoretical and practical knowledge of the main methodologies (both classical and instrumental) for the quantitative determination of substances of pharmaceutical and toxicological relevance, with reference to the Official Pharmacopoeia.

Introduction to the course and general concepts related to quantitative pharmaceutical analysis.

Volumetric methods in quantitative analysis:

Expression of solution concentration; acid-base, solubility, redox, and complexation equilibria; acid-base, precipitation, complexometric, and redox titrations.

Instrumental methods in quantitative analysis:

UV/Visible spectroscopy: general concepts; instrumentation; Lambert-Beer’s law and its application in quantitative analysis; calibration curve using the external standard method; matrix effect.

Chromatographic techniques: general concepts in gas chromatography and liquid chromatography (classical, HPLC, UPLC, TLC); stationary and mobile phases; instrumentation; applications in quantitative analysis; calibration curves using the external standard, internal standard, and standard addition methods.

The practical sessions, the schedule of which will be communicated by the lecturer at the beginning of the course, focus on the analysis of substances of pharmaceutical and toxicological interest, with reference to the Official Pharmacopoeia.

To take the exam, students must have passed the exam in General and Inorganic Chemistry and the exam in Analytical Chemistry with laboratory. To attend the practical laboratory sessions, students must have passed the exam in General and Inorganic Chemistry and have attended the course in Analytical Chemistry with laboratory.

D1-KNOWLEDGE AND UNDERSTANDING

The student is expected to have acquired both theoretical and practical knowledge of the main classical and instrumental quantitative analytical techniques. They should be able to understand the most recent analytical techniques used for the quantitative determination of active pharmaceutical ingredients in various complex systems, in drug stability controls, and for the assessment of drug purity. These skills will be evaluated through laboratory activities.

D2-APPLYING KNOWLEDGE AND UNDERSTANDING

The student should demonstrate the ability to select and apply the most appropriate quantitative analytical techniques for the determination of pharmaceutical substances listed in the Official Pharmacopoeia, in systems of varying complexity, obtaining valid and verified results. The student should also be capable of planning and applying an analytical method.

D3-AUTONOMY OF JUDGMENT

The student should demonstrate the ability to critically and independently select the most appropriate analytical method, producing effective results. They should also be able to interpret experimental data and results. These skills will be assessed through targeted oral questions of an applied nature.

D4-COMMUNICATION

By the end of the course, the student should be able to clearly present the acquired knowledge using appropriate terminology for correct scientific communication regarding methodologies and issues related to the quantitative analysis of pharmaceutical substances. The student should also be able to organize and present clear and comprehensive reports.

D5-LIFELONG LEARNING SKILLS

The student should demonstrate good autonomy in performing quantitative analyses of pharmaceutical substances described in the Official Pharmacopoeia and show the ability to conduct literature and/or online research on alternative and innovative methods, thereby supporting continuous and up-to-date learning.

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

No teaching support activities are planned.

Teaching

Frontal lectures and individual or group laboratory exercises.

Innovative teaching methods

The laboratory-based teaching approach will be enriched with individual and group exercises and in-depth activities, following the "learning by doing" method.

Attendance

Attendance to lectures is not mandatory but strongly recommended in order to successfully carry out the practical laboratory sessions. Access to the laboratory requires having passed the General and Inorganic Chemistry exam and having attended the Analytical Chemistry with Laboratory course.

Course books

Textbooks:

• A. Carrieri, Manuale di Analisi quantitativa dei Medicinali, Ed. EdiSES
• D. G. Watson, Analisi Farmaceutica, terza edizione, Ed. Edra

Additional reference texts:

• Official Pharmacopoeia
• V. Cavrini, V. Andrisano, Principi di analisi farmaceutica, Ed. Esculapio
• D. A. Skoog, D. M. West, Fondamenti di Chimica Analitica, Ed. Zanichelli

Assessment

Upon approval of the practical laboratory component, whose expected learning outcomes will be assessed through written reports on the laboratory experiences, the assessment of learning includes a written exam, the successful completion of which grants access to the oral exam. The exams aim to verify the student's acquisition of the theoretical concepts presented during lectures and the practical procedures carried out during the laboratory sessions. The student is expected to demonstrate knowledge of classical and instrumental techniques used to determine drug purity and to perform quantitative analysis of active pharmaceutical ingredients in systems of varying complexity. The ability to connect topics covered during the course and to address practical and applied problems will also be evaluated. The overall assessment is graded on a scale of 30 points.

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.

Teaching

No recovery activities are planned.

Attendance

Attendance to lectures is not mandatory but strongly recommended in order to successfully carry out the practical laboratory sessions. Access to the laboratory requires having passed the General and Inorganic Chemistry exam and having attended the Analytical Chemistry with Laboratory course.

Course books

Textbooks:

• A. Carrieri, Manuale di Analisi quantitativa dei Medicinali, Ed. EdiSES
• D. G. Watson, Analisi Farmaceutica, terza edizione, Ed. Edra

Additional reference texts:

• Official Pharmacopoeia
• V. Cavrini, V. Andrisano, Principi di analisi farmaceutica, Ed. Esculapio
• D. A. Skoog, D. M. West, Fondamenti di Chimica Analitica, Ed. Zanichelli

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Assessment

Upon approval of the laboratory practical component, the learning outcomes of which will be assessed through written reports on the practical laboratory experiments, the final assessment consists of an oral exam aimed at verifying the student’s acquisition of the theoretical concepts presented during lectures and the practical procedures used in the laboratory sessions. The student will be required to demonstrate knowledge of classical and instrumental techniques used to assess drug purity and to carry out the quantitative analysis of active pharmaceutical ingredients in systems of varying complexity. The student’s ability to integrate topics covered during the course and to solve practical and applied problems will also be evaluated. The oral exam is graded on a scale of 30 points.

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.