
Course unit
DRUG ANALYSIS 2 (Iniziali cognome MZ)
MEP3051759, A.A. 2019/20
Information concerning the students who enrolled in A.Y. 2016/17
ECTS: details
Type 
ScientificDisciplinary Sector 
Credits allocated 
Core courses 
CHIM/08 
Pharmaceutical Chemistry 
12.0 
Course unit organization
Period 
First semester 
Year 
4th Year 
Teaching method 
frontal 
Type of hours 
Credits 
Teaching hours 
Hours of Individual study 
Shifts 
Laboratory 
4.0 
60 
40.0 
No turn 
Lecture 
8.0 
64 
136.0 
No turn 
Prerequisites:

The student must possess an adequate cultural background that includes knowledge of:
 General and inorganic chemistry and stoichiometry, in particular chemical equilibria in solution, solubility, buffer solutions, pH and indicators, acidbase, chelating and redox reactions.
 Organic chemistry, in particular the most important organic solvents, solubility of organic compounds, transformation reactions and functional groups.
 Qualitative instrumental analysis, in particular the basic theoretical principles of the most common techniques (IR, UVVis, fluorimetry and chromatographic techniques).
 Basic statistical principles.
 Laboratory safety.
It is mandatory to have passed the Drug Analysis 1 and Analytical Chemistry with Elements of Statistics exams. To access the laboratory, the student must have attended the laboratory of the Drug Analysis 1 course. 
Target skills and knowledge:

The course of Drug Analysis 2 aims at providing students with the theoretical and practical tools to carry out quantitative analyses of the active principles described or not in the Official Italian Pharmacopoeia (FUI), both raw materials and in solid (e.g. tablets) and liquid (e.g. solutions) pharmaceutical forms. In the first case, the analyses are aimed at verifying the purity of the raw material used in the preparation of the drugs, in the second, the quantity of active principle declared in the pharmaceutical preparation. The student will be able to carry out quantitative chemical analyses i.e. to prepare and to standardize solutions for the different types of titration reactions, to make quantitative determinations, to use precisely manufactured glassware. Moreover, they will be able to acquire skills in the calculations that lead to the final result by applying the theoretical concepts of statistical data processing and to evaluate the final result in a critical way. Furthermore, the student, supported by the specific theoretical concepts, will be able to carry out determinations of compounds of pharmaceutical interest by means of various instrumental techniques and above all, to apply different methods of analysis both of general (calibration curve) and specific type (application of LambertBeer Law). In summary, students will be able to use the main laboratory techniques and to apply, with a critical approach, the most suitable analytical procedures for an accurate and precise quantitative chemical analysis. 
Examination methods:

The examination consists of a written test divided into two parts. The first part provides for the solution of two analytical problems such as the determination of the title of a reagent or the concentration of a pharmaceutical compound, either by volumetric titrations, or by application of LambertBeer's law. The second part of the examination consists of open questions concerning both the different types of titrations treated and the principles and applications of the instrumentation for the quantitative determination of drugs described during the course. 
Assessment criteria:

The assessment of the student's preparation will be based on the understanding of the topics covered and the student's ability to rework the concepts covered during the course in order to transform the knowledge learned into a reflection that presents traits of originality. The student will also be assessed on the ability to apply the theoretical concepts acquired in a logical and autonomous way, being able to apply the chemical and analytical methodologies learned in areas other than those strictly covered in the course. The student who has passed the exam with profit must be able to convey, in a clear and complete way, the knowledge acquired in the quantitative analysis of the drug. 
Course unit contents:

The course of Drug Analysis 2 (quantitative analysis) aims at providing students with the theoretical and operational tools to perform quantitative chemical analysis involved in several categories such as basic research, biotechnology, food control, clinical chemistry, agriculture, materials science and more.
Analytical chemistry, in fact, covers important aspects in many fields and is essential for students to understand the analytical techniques both basic (titration, dosages, calculations) and of more recent conception (spectrofluorimetry, high performance liquid chromatography, gas chromatography, capillary electrophoresis).
The main topics of the quantitative chemical analysis concern in particular with the titrations, the preparation and standardization of reagents, the quantitative chemical calculations of compounds, metals and drugs registered in the FUI. Particular attention is devoted to the chemical reactions involved in the titrations and to the quantitative aspects that comes from them (stoichiometric coefficients, molar ratios between reagent and analyte).
The instrumental part is mainly dedicated to the explanation of the methods of analysis and their application in pharmaceutical analysis, while the different instrumentations and the theoretical principles of their functioning are treated in a way focused at the quantitative analysis.
It is also essential to provide the student with the criteria to correctly choose a method of analysis and evaluate the obtained experimental results.
It should be noted that both individual and group laboratory exercises, are meant to offer appropriate examples of the most important analytical techniques, with the aim of stimulating the critical and organizational aspect necessary to carry out the analysis. 
Planned learning activities and teaching methods:

The course consists of 64 hours of frontal lessons and 60 hours of individual and group laboratory exercises.
(a) Frontal lessons
Frontal lessons include the use of slides explained in detail, recalling, if necessary, notions of the propaedeutic courses. Whenever possible, theoretical lessons take place in parallel with laboratory exercises so that students can compare the experimental experience with theory. The theoretical part of the course is set according to a scheme that, starting from the basic concepts, leads progressively, through the concept of titration of an active principle according to FUI, to more complex approaches, such as the external and internal standard methods in a calibration curve applied to the most advanced instrumental techniques. During the course, problem solving are also carried out with the participation of the students.
(b) Laboratory exercises
The laboratory exercises are carried out daily, by dividing the students into groups. Some lessons describing the practical arrangements and theoretical explanations to perform correctly the chemical titrations and instrumental analyses are provided before laboratory exercises. Each student has a personal workstation and the necessary equipment (glassware, instrumentation, etc.). The students are engaged for about 3.5 hours a day, time sufficient to carry out the planned experience. The students are watched by both the teacher and technicians for the correct use of the instrumentation and for the execution of the analyses. At the beginning of the exercises, to each student an "exercises guide" is given, describing in detail the procedures to be followed for both the titrations and instrumental parts of the exercises.
The preparation of the titration reagents, the titrations and the relative quantitative determinations are carried out individually and the student must prepare a complete report of the calculations performed in order to reach the required result.
Instrumental determinations are carried out in groups of 23 or 56 students. Each group presents a detailed report of all analysis performed.
After correction, all the reports are returned to the students. Students are encouraged to keep, as a good laboratory practice, a "laboratory notebook" in which they can record any observations useful for carrying out the analysis and its possible repetition, and in particular, the calculations.
The laboratory exercises aims to provide to the students the analytical methods required to carry out analyses of pharmaceutical principles, and to introduce the student into the complex world of pharmaceutical analysis. 
Additional notes about suggested reading:

To support teaching, slides of the lessons are published on the University's Moodle platform (https://elearning.unipd.it/dsf/).
The following texts are recommended. 
Textbooks (and optional supplementary readings) 

Cavrini, Vanni; Andrisano, Vincenza, Principi di analisi farmaceuticaCavrini V., Andrisano V. Bologna: Esculapio, 2017.

Harris, Daniel C., Chimica analitica quantitativaDaniel C. Harris. Bologna: Zanichelli, 2005.

Cozzi, Renato; Protti, Pierpaolo, Analisi chimicamoderni metodi strumentaliR. Cozzi, P. Protti \e! T. Ruaro. Milano: CLUED, \poi! Milano, ESU, \poi! Bologna, .

, Farmacopea Ufficiale Italiana XII Edizione. : , .


