FLVKA0361 - Pharmaceutical Analytical Chemistry

To enable students to develop and use analytical chemical methods in connection with development of drug substances, as well as identification and quality assessment of drugs and excipients.

Students must have accumulated at least 15 ECTS credits in chemical subjects, of which 10 ETCS credits must be in the field of organic chemistry.

Study groups and exercises constitute an integrated course package.

The course provides a background for selecting and developing analytical methods and assessing the reliability of analytical data. A variety of analytical techniques are described with regard to their use in quantitative determination and identification. Teaching will focus on the design and use of apparatus as well as potential sources of error. There will also be focus on quality assurance and validation of analytical methods, including the significance of linearity, accuracy, precision, sensitivity, determination limits, blind values, selectivity and interference. Study groups are used to discuss theoretical background. The students take turns giving 30-minute presentations on  theoretical subjects, which are subsequently discussed and related to the practical experiments.

In the practical exercises, students work with fixed demonstrations of separation and detection methods. They simultaneously work on a project where they plan and try out a number of these techniques on a given drug. The analytical techniques are liquid chromatography (HPLC), gas chromatography (GC), capillary electrophoresis (CE), UV-VIS spectrophotometry, fluorometry, mass spectrometry (MS), atomic absorption spectrometry (AAS) and potentiometric methods. The students carry out experiments in groups and submit a joint report. Reports are assessed by the teacher and discussed on return.

At the end of the course, students should:

1. Have adequate theoretical and practical knowledge of a wide variety of analytical chemical techniques to independently plan and perform quantitative determinations using relevant analytical methods
2. Be able to explain the principle of the techniques, their areas of application and potential sources of error
3. Master the methodological terminology required for reading literature and writing reports
4. Master quantitative calculations based on various calibration methods in connection with the analytical chemical methods applied
5. Be able to assess the reliability of analytical data
6. Be able to report experiments briefly, clearly and unambiguously.

Registration for the exam is contingent on approval of all reports from the laboratory exercises.

Exam form
Individual oral exam with preparation time. The student is examined on the basis of two reports selected by lot. After the report selection, the student has 30 minutes’ preparation time with the help of all written materials.

Pass criteria
To pass the exam, the student should be able to describe the analytical methods applied in the selected reports and demonstrate ability to perform quantitative determinations based on analytical data.

Description of grades

12 Excellent performance
The student demonstrates a high-level command of all aspects of the relevant material, with no or only a few minor weaknesses.  

7 Good performance
The student demonstrates a good command of the relevant but also some weaknesses. 

2 Acceptable performance
The student meets only the minimum requirements. 

Bente Gammelgaard, Department of Pharmaceutics and Analytical Chemistry