91022 - Drug Analysis II

Learning outcomes

The aim of the course is to provide theoretical and practical knowledge about the different methods for the identification of drug substances. In particular, attention will be paid to the identification methods (both chemical and instrumental) prescribed by the European Pharmacopoeia. The course includes laboratory activity.

Course contents

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).

The course will include single-seat laboratory exercises related to the program topics.

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 10th Ed.

Teaching methods

The course includes theoretical lessons and laboratory practice and 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 is to be attended in class. Information about Module 3 attendance schedule is available on the website of your degree programme

Assessment methods

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.

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.

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