- Docente: Vincenza Andrisano
- Credits: 6
- SSD: CHEM-07/A
- Language: English
- Moduli: Vincenza Andrisano (Modulo 1) Michele Protti (Modulo 2)
- Teaching Mode: In-person learning (entirely or partially) (Modulo 1); In-person learning (entirely or partially) (Modulo 2)
- Campus: Rimini
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Corso:
Single cycle degree programme (LMCU) in
Pharmacy (cod. 5987)
Also valid for Single cycle degree programme (LMCU) in Pharmacy (cod. 5987)
Learning outcomes
At the end of the course the students will have the theoretical and practical knowledge to carry out the determination of active principle in health products (nutraceuticals, dietary supplements, functional foods, cosmetics) and drug substances in drug products and to apply the pharmacopoeial methods for the quality control of health products and drug substances and their dosage forms. Attention will be paid to the methodologies for the sample preparation. The course includes laboratory activity.
Course contents
Module 1 (Frontal lessons) Theory
Application of Sample preparations (L/S, L/L, SPE, Micro-SPME extractions) for pharmaceutical and nutraceutical formulations. Applications of Analytical methods for pharmaceutical and nutraceutical formulation analysis. Method validation . Characterization of nutraceutical Standards for method validation in the analysis of active principle in pharmaceutical and nutraceutical formulations Stability studies. Kinetics of degradation. Accelerated stability.
Analytical advanced methodologies (HPLC, GC, HPLC-MS, fluorometry, HPLC-DAD, UV-VIS, etc.) and sample preparation for the analysis of health product formulations belonging to the categories reported in the European Pharmacopoeia in view of purity, quality control and stability studies of active principle and pharmaceutical and nutraceutical formulations. Validation of the methods and determination of validation parameters.
Non aqueous titrations
Module 2 (laboratory practice)
Laboratory exercises to individual places with the aim of deepening the practical aspects related to the main methods of analysis to determine the active ingredients in the context of quality control and stability studies.
The training on safety must be carried out in advance in order to participate to laboratory activities.
- Non-aqueous titration of weak bases and hydrochlorides (sodium acetate, nicotinamide, alanine)
- Non-aqueous titration of weak acids (Sulfonamide drugs)
- Sodium benzoate Liquid-liquid extraction from syrup and titration
- Quinine Liquid-liquid extraction from a syrup and UV spectrophotometric determination
- High performance liquid chromatography- UV detection (HPLC-UV) determination of acetylsalicylic acid in Aspirin tablets
- Gas-chromatography flame ionization detection (GC-FID) determination of camphor and menthol in a pharmaceutical gel
- Colorimetric determination of Fe (II) in pharmaceutical formulations (tablets)
- Colorimetric determination of aromatic amines (procaine hydrochloride) in pharmaceutical solutions
- Determination of guaifenesine in a syrup by gas-chromatography flame ionization detection (GC-FID) after solid phase extraction (SPE).
Readings/Bibliography
1) Pharmaceutical Analysis, by David G. Watson, third edition, Elsevier ed.
2) V. CAVRINI, V. ANDRISANO, Principi di Analisi Farmaceutica, terza edizione, Esculapio, 2017.
3) Quantitative Chemical Analysis, by Daniel C. Harris, Charles A. Lucy
4) Analytical Chemistry and Quantitative Analysis, by David S. Hage, James R. Carr
Teaching methods
Frontal lessons and lab practise
The theoretical lessons and lab activity are intended to provide the knowledge of instrumental techniques used in pharmaceutical and nutraceutical analysis.
In order to take the examination, the student must have attended at least 80% of the laboratory experiments and 70% of the lectures.
Assessment methods
During the laboratory activity the learning is assessed by the discussion of the achieved experimentals skills. A final lab examination consists in the application of analytical methodologies to verify the skills of the students.
The final test will be an oral presentation about subjects dealt during the course.
Regarding learning assessment, the use of AI is prohibited. Any use constitutes a violation of academic integrity.
Students with Specific Learning Disorders or temporary or permanent disabilities: it is recommended to contact the competent University office in good time (https://site.unibo.it/studenti-con-disabilita-e-dsa/en ); the office will propose any adaptations to the students concerned, which must in any case be submitted, 15 days in advance, for the approval of the lecturer, who will assess their appropriateness also in relation to the learning objectives of the course unit.
Teaching tools
Theoretical lessons will be held by using slides.
In the laboratory activity the students will use analytical instrumentation such as: conductometers, potentiometers, spectrophotometer, pH-meter, liquid and gas chromatographs (GC and HPLC), suitable for the drug quality control.
Office hours
See the website of Vincenza Andrisano
See the website of Michele Protti