Drug Analysis

Course Description_Drug Analysis

    SUBJECT:  DRUG ANALYSIS

 SYLLABUS of LECTURES

Winter semester 2026/2027

Term:                  Wednesday, 7:30 – 11:00

Place:                  Room O419, 4^th floor, Odbojárov 10

Lecturers:          PharmDr. Iva Kapustíková, PhD.

                              doc. PharmDr. Katarína Maráková, PhD.

                              PharmDr. Mária Bodnár Mikulová, PhD.

1^st week: Drug analysis, content, and importance of the subject. The European Pharmacopoeia: General chapters, Monographs. European Directorate for the Quality of Medicines & HealthCare.

PharmDr. Iva Kapustíková, PhD.

2^nd week: Qualitative analysis: Identification reactions of ions and functional groups.

PharmDr. Iva Kapustíková, PhD.

3^rd week: Qualitative analysis: Identification reactions of organic drugs. Group reactions and selective reactions.

PharmDr. Iva Kapustíková, PhD.

4^th week: Physical and physicochemical methods – General chapters in the European Pharmacopoeia – Part I.

PharmDr. Iva Kapustíková, PhD.

5^th week: Physical and physicochemical methods – General chapters in the European Pharmacopoeia – Part II.

PharmDr. Iva Kapustíková, PhD.

6^th week: Physical and physicochemical methods – General chapters in the European Pharmacopoeia – Part III.

PharmDr. Iva Kapustíková, PhD., doc. PharmDr. Katarína Maráková, PhD.

7^th week: Purity of drugs and its control. Physical and physicochemical methods used in purity tests.

PharmDr. Iva Kapustíková, PhD.

8^th week: Purity of drugs and its control. Limit tests for inorganic impurities.

PharmDr. Iva Kapustíková, PhD.

9^th week: Quantitative analysis: Gravimetry. Volumetric methods in the European Pharmacopoeia – Part I.

PharmDr. Iva Kapustíková, PhD.

10^th week: Quantitative analysis: Volumetric methods in the European Pharmacopoeia – Part II.

PharmDr. Iva Kapustíková, PhD.

11^th week: Chemical analysis of drug substances. Quality control of the final pharmaceutical product. 

PharmDr. Iva Kapustíková, PhD., PharmDr. Mária Bodnár Mikulová, PhD.

12^th week: Good manufacturing practice. Validation in pharmaceutical analysis. Technical norms. Pharmaceutical analysis in registration of medicinal products.

PharmDr. Iva Kapustíková, PhD.

13^th week: Stability of medicinal products. Quality control of containers and materials used for the manufacture of containers. Computational exercises.

PharmDr. Iva Kapustíková, PhD.

Bratislava 14^th September 2026

PharmDr. Iva Kapustíková, PhD.                                                                                          

         responsible teacher                                                                

SUBJECT:  DRUG ANALYSIS 

SYLLABUS of LABORATORY PRACTICALS

Winter semester 2026/2027

Term:            Friday, 7:30 – 12:30    (25. 9., 9. 10., 23. 10., 6. 11., 20. 11., 4. 12.)

Place:            Laboratory O304 and O310a, 3^rd floor, Odbojárov 10

Teachers:     PharmDr. Iva Kapustíková, PhD.

1^st week: Qualitative analysis: Identification reactions of ions and functional groups – Inorganic ions.

3^rd week: Qualitative analysis: Identification reactions of ions and functional groups – Organic groups.

5^th week: Qualitative analysis: Identification reactions of drugs. Physical and physicochemical methods: Relationship between reaction of solution, approximate pH and colour of certain indicators; Potentiometric determination of pH; Conductivity. Preliminary test.

7^th week: Physical and physicochemical methods: Melting point – capillary method; Relative density; Refractive index; Optical rotation; Absorption spectrophotometry, ultraviolet and visible; Infrared spectroscopy; Thin layer chromatography.

9^th week: Purity of drugs and its control. Limit tests for inorganic impurities. Preliminary test.

11^th week: Quantitative analysis. Titrimetric methods.

Two preliminary tests are taking place during the 3^rd and 5^th laboratory practicals. Student must achieve at least 60 % in each test to pass. If the student does not pass one of the tests, he/she will take the first retake preliminary test in the last week of the semester. In case student does not pass two of the tests, he/she will take a first retake summary preliminary test in the last week of the semester. In the case the student does not pass first retake preliminary test in the last week of the semester, he/she has the opportunity to write a second retake preliminary test in January 2027. If student fails on second retake term, he/she must enrol the subject in the next academic year.

Bratislava 14^th September 2026

PharmDr. Iva Kapustíková, PhD.                                                                                           

         responsible teacher                                                                                                                                

SUBJECT:  DRUG ANALYSIS

ORGANISATION of the FINAL EXAMINATION

Winter semester 2026/2027

Students must use university e-mail to communicate. There is no other way to validate their identity in the study process.

Conditions for admitting student to the final examination are as follows:

1.  successful graduation of 2 preliminary tests during the semester, i.e. at least 60 % in each test,

2.  100 % attendance at laboratory practicals.

Final examination is performed in written form. The exam consists of questions where all the content of Drug Analysis lectures and laboratory practicals will be represented. Student must obtain at least 60 % in order to pass exam. Scale of assessment (preliminary/final): 20/80.

The number of students registered for the final examination is unlimited. The registration for the final exam must be done via an AiS2 system only. The dates and organisation of the exam will be notified via AiS2 system according to current regulations.

Exams are divided to regular term, first and second reparation. If obtained score in the second reparation is lower than 60 %, student can enrol subject Drug Analysis next academic year.

Classification system: A: 100–92 %; B:  91–84 %; C:  83–76 %; D:  75–68 %; E:  67–60 %; FX:  <60 %.

Study materials:

• Lectures are available on Moodle.
• The European Pharmacopoeia. 12th Ed. Strasbourg: Council of Europe, 2025.
• Hansen, S., Pedersen-Bjergaard, S., Rasmussen, K.: Introduction to Pharmaceutical Chemical Analysis. Chichester: John Wiley & Sons, 2012.
• Kapustíková, I.: Drug Analysis, Laboratory Practicals. Bratislava: Comenius University in Bratislava, 2020.
• Kar, A.: Pharmaceutical Drug Analysis. New Delhi: New Age International, 2005.
• Pedersen, O.: Pharmaceutical Chemical Analysis. Methods for Identification and Limit Tests. New York: CRC Press, Taylor & Francis Group, 2006.
• Rouessac, F., Rouessac, A.: Chemical Analysis. Modern Instrumentation Methods and Techniques. 2nd Ed. Chichester: John Wiley & Sons, 2007.
• Watson, D. G.: Pharmaceutical Analysis. A Textbook for Pharmacy Students and Pharmaceutical Chemists. 4th Ed. Edinburgh: Elsevier, 2017. 

Bratislava 14^th September 2026

PharmDr. Iva Kapustíková, PhD.                                                                                          

         responsible teacher                                                                                                                                

Kapustíková, I.: Drug Analysis, Laboratory Practicals. Bratislava: Comenius University in Bratislava, 2020. ISBN 978-80-223-5055-6.