91022 - Drug Analysis II (Gr.B)

Learning outcomes

The aim of the course, which includes laboratory activities, is to provide theoretical and practical knowledge about the different analytical methods aimed at the identification of compounds of pharmaceutical interest, focusing on both chemical and instrumental methods reported in the European Pharmacopoeia. The student will learn how to manage and solve problems concerning the qualitative drug analysis and the quality control of compounds of pharmaceutical interest and to report and discuss the results.

Course contents

Module 1

Introduction: Program and aims of the course. The European Pharmacopoeia.

Solubility. Solubility of inorganic salts, solubility product and chemical equilibrium shift. Dissolution process of organic substances, solvent properties (polarity, dielectric constant), relationships between chemical structure of solute and solubility. Solubility assays.

Chemical analysis of drugs. Analysis of inorganic substances: recognition reactions of cations (silver, mercury, bismuth, copper, aluminum, iron, zinc, calcium, barium, magnesium, sodium, lithium, potassium, ammonium ion) and anions (chlorides, bromides, iodides, acetates, sulfates, phosphates, carbonates and bicarbonates, nitrates). Flame assay. Analysis of functional groups of organic substances: reactions of analytical utility for alkenes, aromatic systems, alcohols, phenols, aldehydes, ketones, amines, acids and derivatives.

Determination of physical constants. Boiling point, melting point, density, refractive index, specific rotational power.

Spectroscopic techniques. Infrared Spectroscopy: principles, instrumentation, interpretation of IR spectra of compounds of pharmaceutical interest. Nuclear Magnetic Resonance (NMR) Spectroscopy: principles and applications.

Extractive techniques. Liquid-solid extraction, liquid-liquid extraction (partition coefficient, effect of pH and electrolytes).

Introduction to chromatographic techniques. The chromatographic process. Chromatographic separation mechanisms (adsorption, partitioning, ion exchange, molecular exclusion, affinity). Column and thin layer chromatography (TLC).

Mass Spectrometry. Principles and Applications.

Module 2

Module 2 will include single-seat laboratory exercises related to the qualitative analysis of drugs.

Readings/Bibliography

Shrine, Hermann, Morrill, Curtin, Fuson

THE SYSTEMATIC IDENTIFICATION OF ORGANIC COMPOUNDS

Wiley - 8th ed. 2004 (or subsequents) .

 

David G. Watson

PHARMACEUTICAL ANALYSIS

Elsevier - 5th ed. 2020

 

V. Cavrini, V. Andrisano

PRINCIPI DI ANALISI FARMACEUTICA

Esculapio - 4th ed. 2017

 

A. Carrieri et al.

MANUALE DI ANALISI QUANTITATIVA DEI MEDICINALI

EdiSES - 2019

 

European Pharmacopoeia

Teaching methods

The course consists of in-person theoretical lectures and laboratory sessions. Attendance is mandatory for both.

As concerns the teaching methods of this course unit, all students must attend Module 1, 2 [https://www.unibo.it/en/services-and-opportunities/health-and-assistance/health-and-safety/online-course-on-health-and-safety-in-study-and-internship-areas] online, while Module 3 on health and safety must be attended in class. Information about Module 3 attendance schedule is available on the website of your degree programme

Assessment methods

In order to take the examination, the student must have attended at least 80% of the laboratory exercises and 70% of the lectures. Students are reminded to check the prerequisites listed in the course structure diagram.

Students with learning disorders and\or temporary or permanent disabilities: please, contact the office responsible (https://site.unibo.it/studenti-con-disabilita-e-dsa/en/for-students) as soon as possible so that they can propose acceptable adjustments. The request for adaptation must be submitted in advance (15 days before the exam date) to the lecturer, who will assess the appropriateness of the adjustments, taking into account the teaching objectives.

At the end of the laboratory practice, the student should sit for a test which consists in the identification of two drugs by using the methods described in the European Pharmacopoeia and in writing a report for each of them.

With regard to the assessment of learning, the use of artificial intelligence (AI) is prohibited. Any use of AI constitutes a violation of academic integrity.

The final assay consists of an Oral Examination aiming at verifying the knowledge acquired as stated by the learning outcomes. This examination, which could also include the reading and discussion of some of the monographs of the European Pharmacopoeia, shall be considered positive on the basis of the correct answers to questions related to the topics covered during the course.

 The Oral Examination is designed to assess the student's level of learning by evaluating their ability to apply the knowledge acquired, develop logical and deductive reasoning, and critically discuss the topics covered during the course.

Grading criteria:

• 18–19: Knowledge limited to a portion of the course topics; analytical skills demonstrated mainly with the guidance of the examiner; overall correct use of scientific terminology.
• 20–24: Knowledge covering a significant portion of the course topics; ability to perform independent analysis limited to the practical and procedural aspects of laboratory work; clear presentation and appropriate use of technical terminology.
• 25–29: Broad knowledge of the course topics; ability to critically analyse the topics covered; sound command of discipline-specific terminology.
• 30–30 e lode: Comprehensive and thorough knowledge of all course topics; ability to critically analyse, integrate and connect the different topics covered in the course; full command of discipline-specific terminology, supported by strong reasoning and argumentation skills.

Teaching tools

The theoretical lessons will be held by using common audio-visual means.
The laboratory practice will be carried out individually by each student, in laboratories equipped with all necessary chemical reagents and instrumentations.

Office hours

See the website of Rita Morigi