95844 - Advanced Analysis of Health Products

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

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.

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).
• Potentiometric titration of phosphoric acid

Readings/Bibliography

1) V. CAVRINI, V. ANDRISANO, Principi di Analisi Farmaceutica, terza edizione, Esculapio, 2017.

2) Quantitative Chemical Analysis, by Daniel C. Harris, Charles A. Lucy

3) 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.

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.

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 Serena Montanari