501328 - Pharmaceutical Analysis 2

courses

ID:

501328

Duration (hours):

88

CFU:

SSD:

CHIMICA FARMACEUTICA

Year:

2025

Date/time interval

Primo Semestre (29/09/2025 - 23/01/2026)

Course Objectives

The educational objective of the course is to provide students with basic and specific knowledge of the main analytical methodologies (volumetric and instrumental) described in the Official Pharmacopoeias and in the scientific literature for the quantitative determination of compounds of pharmaceutical interest. The course also intends to provide the theoretical foundations for the interpretation of the analytical results and the evaluation of its reliability. This teaching outlines the fundamental guidelines for the implementation of quantitative analyzes in the complex drug discovery and development process as well as for the implementation of typical quality control protocols. At the end of the course the student will have acquired the basis for a correct interpretation and execution of the quantitative assays reported in the pharmacopoeia monographs and scientific literature in general.

Course Prerequisites

The topics covered during the course require the knowledge and skills provided by the courses of: General and Inorganic Chemistry, Analytical Chemistry, Organic Chemistry 1, and Organic Chemistry 2 with elements of spectroscopy and Pharmaceutical Analysis 1.

Teaching Methods

The course includes lectures and calculation exercises led by the teacher on the topics covered in class. The frontal lessons (7 CFU) will be carried out through the projection of presentations (PowerPoint). All educational material is made available on the Kiro platform. When appropriate, the "problem solving" approach will be adopted, thus inviting students to actively participate in the lessons. Laboratory practice (2 CFU) include single-seat laboratory practice (16 hours), group laboratory practice (8 hours), classroom exercises (8 hours) using an HPLC simulator. The practice are mandatory. In detail: 1. The single-seat practice are aimed at the preparation of standard solutions and the dosage of products of pharmaceutical interest according to F.U. (acid-base, silver-based, complexometric and redox titrations; 2. Group practice will be focused on potentiometric titrations and quantitative determination of drugs by UV-Vis spectroscopy; 3. Classroom practice will be carried out using an open source HPLC simulator and will be guided by the teacher. The single-seat activity will be evaluated based on the percentage error of the individual volumetric analysis exercises. Furthermore, at the end of the classroom exercises, the student will have to present a commented report. To complete the educational offer, 24 hours of support tutoring are provided during the practical laboratory. The course also includes 4 hours of seminar activities carried out by professional figures from the pharmaceutical industry who will provide an insight into the role of analysis in the pharmaceutical sector and possible professional opportunities.
For students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Modality, adequate teaching material will be available for fruitful independent study. If requested, self-learning can be supported by tutoring or supplementary teaching activities, and by dedicated meetings, including online, with time flexibility depending on needs.

Assessment Methods

The acquisition of the credits (9 CFU) is linked to the positive evaluation of the written test at the end of the course or on the exam dates and positive evaluation of the laboratory tests. Furthermore, the student must have submitted the written report on the classroom exercises. The quality of the final report will contribute to the final assessment. The written test includes 8 open questions including 2 numerical calculation exercises.

Texts

Harris D. C., "Chimica analitica quantitativa", Zanichelli Ed.; David S. Hage, James D. Carr “Chimica Analitica e Analisi Quantitativa” PICCIN Editore Watson"Analisi farmaceutica" EdiSES. Skoog, West, Holler “Fondamenti di chimica analitica” EdiSES. Bauer, Christian, O’Reilly "Analisi strumentale" PICCIN Editore.

Introduction: scope of quantitative pharmaceutical analysis. Steps for a quantitative analysis. Mass and volume measurements and related errors. Foundamentals of gravimetry. Volumetric analysis: general principles and classification of methods; primary and secondary standards; preparation and standardization of solutions. Acidimetry and alkalimetry, acid-base titrations in a non-aqueous environment, argentometry, chelometry, redox titrations. Applications reported in F.U. For each type of titration, examples reported in the Official Pharmacopoeia will be commented. Introduction to potentiometry. Potentiometric titrations: reference electrodes and indicator electrodes. Applications of potentiometric titrations. Spectroscopic methods: molecular absorption spectroscopy and Lambert-Beer law. Characteristics and application of molecular fluorescence. Quantitative analysis by chromatography. HPLC detectors: fluorescence detector, light scattering detector, refractive index detector. Quantitative analysis and calibration (normalization, external standard method, internal standard method, standard addition method, calibration in LC-MS and use of deuterated internal standards). Surface plasmon resonance for the determination of the drug-receptor affinity constant.

Course Language

Italian

More information

The teacher is available in her office for explanations and revisions of assignments by appointment by email. To attend the laboratory practice, students must have completed the online training course on Safety and Health in the workplace.