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Pharmaceutical Analysis II - GAF306
Title: Pharmaceutical Analysis II
Guaranteed by: Department of Pharmaceutical Chemistry and Pharmaceutical Analysis (16-16190)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2024 to 2025
Semester: winter
Points: 0
E-Credits: 7
Examination process: winter s.:written
Hours per week, examination: winter s.:28/42, C+Ex [HS]
Capacity: unlimited / unlimited (unknown)
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: taught
Language: English
Teaching methods: full-time
Level:  
Note: deregister from the exam date if a requisite was not fulfilled
course can be enrolled in outside the study plan
enabled for web enrollment
Guarantor: doc. PharmDr. Radim Kučera, Ph.D.
Comes under: 3.ročník 2025/26 Pharmacy (EN19)
Pre-requisite : GAF301, GAF302
Interchangeability : GAF186
Is co-requisite for: GAF322, GAF502
Is pre-requisite for: GAF422, GAF315, GAF350, GAF359
Is interchangeable with: GAF186
Annotation -
Pharmaceutical analysis belongs among the profile subjects taught at the faculty and is part of the state examination. Within the theoretical and practical teaching, the main attention is paid to the issues of management of quality, safety and efficacy of pharmaceuticals, which inevitably fulfills one of the basic functions of pharmaceutical study. The starting point for choice the appropriate method for both identification and quantitative analysis is the structure of the drug. The two-semester course follows the basic knowledge gained in the preparatory subjects of Inorganic Chemistry, Organic Chemistry, Analytical Chemistry and Instrumental Methods. Emphasis is placed on the use of analytical methods in the control-analytical evaluation of pharmaceuticals and pharmaceutical excipients. The teaching is based on the valid European Pharmacopoeia as a basic normative regulation. Pharmaceutical Analysis II follows the subject Pharmaceutical Analysis I. The subject is focused primarily on the use of instrumental methods in analyzing not only APIs (Active Pharmaceutical Ingredients) but also pharmaceutical preparations. Attention is also paid to the evaluation of drug stability, the development of a suitable analytical method, questions on the enantiomeric purity of drugs and also to the basic aspects of the determination of drugs in biological material. Students are further acquainted with the basics of Good Laboratory Practice and Good Manufacturing Practice. During the practical lessons, each student has a pharmacopoeia available to learn a quick orientation in a large amount of factual data.
Last update: Kučera Radim, doc. PharmDr., Ph.D. (30.09.2025)
Course completion requirements -

Requirements  for students, who began their studies in the academic year 2019/2020 and later:

– credit

·         Presence at all seminars and practical training – replacement of excused missed hours can be permitted by the teacher

·         Approved results and reports from all practical tasks

·         Attendance at the lecture about the preparation of samples in bioanalysis – term will be specified in the list of lectures

·         Sufficient knowledge of discussed topics

·         Obtaining more than 50 % of points from practical tasks

 

The exam is written on the following topics:

  • European and other pharmacopoeias (structure, practical skills with use), FDA, EMA, EDQM
  • Identifications using physicochemical methods and General identification reactions
  • Purity of drugs I-III
  • Separation methods I-II
  • UV-Vis spectrophotometry in pharm analysis
  • Assay of drugs I-III
  • Bioanalysis of drugs (introduction and main fields of use, methods for sample preparation)
  • Chirality of drugs from the viewpoint of pharm analysis
  • Gas chromatography use in pharm. analysis

 

 

Requirements for students, who began their studies before academic year 2019/2020:

– credit (credit test)

·         Presence at all seminars and practical trainings – replacement of excused missed hours can be permitted by teacher

·         Approved results and reports from all practical tasks

·         Attendance at the lecture about preparation of samples in bioanalysis – term will be specified in the list of lectures

·         Sufficient knowledge of discussed topics

·         Obtaining of more than 50 % of points from practical tasks

·         Successful passing of the credit test (max. 3 attempts), after reviewing the application the course supervisor may allow a fourth term

Exam is oral according to exam topics uploaded to Study materials

 

Last update: Kučera Radim, doc. PharmDr., Ph.D. (30.09.2025)
Literature -

Recommended:

  • Hansen, Steen Pedersen-Bjergaard, Stig Rasmussen, Knut. Introduction to pharmaceutical chemical analysis. Chichester: Wiley, 2012, 494 s. ISBN 978-0-470-66122-2.

Last update: Kučera Radim, doc. PharmDr., Ph.D. (30.09.2025)
Teaching methods -

Lectures, seminars and practical training

Last update: Kučera Radim, doc. PharmDr., Ph.D. (30.09.2025)
Requirements to the exam
  1. Importance of pharmaceutical analysis and fields of its utilization, regulatory authorities in the field of quality and safety of medicines – EMA, FDA, national authority, European Pharmacopoeia and other pharmacopoeias of world importance, pharmacopoeial monograph, EDQM
  2. Drug identification using physico-chemical methods (melting point, distillation range, boiling point, density, refractive index, optical rotation, solubility, drop point, freezing point)
  3. General reactions and identifications utilized in pharm. analysis (primary aromatic amino-group, phenols, esters, drugs of type BH+X-, tartarates, sulphates, carbonates, hydrogencarbonates, alkaloids, covalently bond sulfur, halogens, sodium, potassium, calcium,  and magnesium ions)
  4. Identification of selected structural types of drugs (derivatives of salicylic acid, natural, semisynthetic, and synthetic morphine analogs, barbiturates, derivatives of benzodiazepines, xanthine derivatives, derivatives of phenylethylamine and phenylisopropylamine, alkaloids from atropine and papaverine group, antibacterial sulfonamides, selected vitamins, and inorganic drugs/excipients)
  5. Identification using chromatographic and spectral methods
  6. Volumetric methods used for drug determination (ways of equivalence point determination, mass equivalent, correction factor of volumetric solution and its determination, direct, indirect and back titrations, blank determination)
  7. Acidimetric/alkalimetic titrations of drugs in aqueous medium
  8. Drug assay based on alkalic hydrolysis of the ester bond
  9. Drug assay of nitrogen-containing drugs using steam distillation
  10. Acidimetric titration of basic drugs in a non-aqueous medium
  11. Assay of salts of organic bases and acids in non-aqueous medium
  12. Alkalimetric titrations of drugs in non-aqueous medium
  13. Chelatometric assay and precipitation titrations of drugs
  14. Redox titrations used for drugs determination (iodometry, bromatometry, permanganometry and cerimetry)
  15. Drug assay with volumetric solution of sodium nitrite
  16. Instrumental methods used for drug assay
  17. Spectrophotometric drug assay
  18. Chromatographic methods for drug assay (HPLC, GC)
  19. Origin of impurities, their effect, importance of purity testing, and the most frequently used methods
  20. Test semimicro-, micro- determination of water, loss on drying
  21. Heavy metals test (individual methods, control and monitoring solution), iron, arsenic, ammonium, including the ninhydrine reaction; test for calcium, magnesium, magnesium and alkaline-earth metals, aluminium, sulfates, cyanides, chlorides, bromides, potassium, phosphates
  22. Test for nitrates, free formaldehyde, peroxides, peroxidic substances, oxidizing substances, reducing substances, oxidisable substances, readily carbonizable substances, sulfated ash, total ash, non-volatile substances, residue on evaporation; appearance of solution (clarity and degree of coloration of liquids, visual evaluation, nephelometry, turbidimetry), acidity or alkalinity, actual acidity, optical rotation, conductivity
  23. Determination of impurities using chromatographic methods (TLC, HPLC, GC – the most frequently used equipment; ways of evaluation; system suitability test – frequently used parameters)
  24. Detection of impurities using spectral methods (UV-Vis, AAS)
  25. Stability of drugs – chemical and physical factors influencing the stability
  26. Stress tests, calculation of kinetic characteristics of decomposition reactions
  27. Accelerated and long-term stability studies, further test, and parameters evaluated in stability studies of pharmaceutical products
  28. Analysis of drugs in biological material (specifics, field of utilization, the most frequently analyzed biological samples – characteristics, collection, storage)
  29. Biological sample preparation methods (precipitation, LLE and SPE)
  30. Analytic methods for evaluation of drugs in biological material (instrumental and immunoanalytic methods – an overview, general principles, comparison of individual methods)
  31. LC-MS and GC-MS  utilization in drug analysis in biological material
  32. Development and validation (evaluated parameters) of an HPLC method for control-analytical evaluation of drugs
  33. Chiral drugs and analytic methods utilized for evaluation of enantiomers and racemates
  34. Gas chromatography utilization in pharmacopoeial analysis and description of instrumentation
  35. Evaluation of residual solvents using GC
Last update: Kučera Radim, doc. PharmDr., Ph.D. (02.10.2025)
Syllabus -

Lectures

  • Stability of drugs, decomposition processes, factors influencing stability

  • Stress testing, accelerated and long-term stability testing, calculation of kinetic characteristics of decomposition reactions

  • Knowledge of chemism of decomposing reactions as a prerequisite for stabilization interventions

  • Volumetric methods used in pharmaceutical analysis

  • Acid-base titrations of drugs (acidimetry, alkalimetry in aqueous and non-aqueous medium)

  • Redox titrations of drugs (iodometry, bromatometry, permanganometry, cerimetry)

  • Complexometric titrations (chlatometry)

  • Drug assay using precipitation titrations

  • Spectrophotometric determination of drugs

  • Polarimetric determination of drugs

  • Determination of drugs using electroanalytical methods

  • Determination of drugs using chromatographic (HPLC, GC) and electrophoretic methods

  • Determination of drugs in biological material

  • Analysis of chiral drugs (purity, assay)

  • Development and validation of a control-analytical method

 

Seminars & Practical training

  • Purity testing of drugs (tests on impurities or degradation products using chromatographic and spectral methods)

  • Assay of drugs (pharmacopoeial methods of quantitative evaluation of drugs)

  • Control-analytical evaluation of pharmaceutical preparations

  • Control of extemporaneously prepared pharmaceutical preparations according to pharmacopoeia and analytical procedures used in laboratories of national authorities

  • Control of mass-manufactured pharmaceutical preparations according to the regulations of producers (control-analytical methods used in release control in pharmaceutical industry)

  • Work with pharmaceutico-analytical literature

  • Tasks solved by semi-demonstrational form (UV spectrophotometry use in Pharmaceutical analysis, IR spectrophotometry use in drug control, analysis of drugs on the basis of specific optical rotation, analysis of drugs using HPLC, monitoring of drugs and metabolites in blood plasma using HPLC)

Last update: Kučera Radim, doc. PharmDr., Ph.D. (30.09.2025)
Learning outcomes

The course Pharmaceutical Analysis II builds upon the knowledge and skills acquired in Pharmaceutical Analysis I and the preceding subjects.

 

After completing the course, students are able to use the following terms (including their commonly used abbreviations) in the correct context related to the analytical evaluation of pharmaceuticals:

Medicinal product – assessment of identity, purity, content determination; bioanalytical methods; biological materials; preparation of biological samples before analysis; acidimetry, alkalimetry, redox titrations, complexometric titrations, precipitation titrations,  potentiometry, amperometry; spectrophotometry; chromatography and used separation modes; mass detection; immunoanalytical methods; chirality, enantiomeric purity; residual solvents; stability of pharmaceuticals; analytical method development; validation, qualification; ICH (International Council for Harmonisation); registration of medicinal products; registration documentation; counterfeit medicinal products, illegal medicinal products.

 Learning Outcomes 

Based on the acquired knowledge and skills, by the end of the module, students will be able to:

 explain the principles of methods used for content determination and assess their advantages and disadvantages;

  • propose a suitable analytical procedure for assessing the content of the active pharmaceutical ingredient, active substance or excipient in a medicinal product based on their chemical structure;
  • calculate and accurately report the result of the content determination;
  • obtain relevant information from the scientific literature and apply it to solve analytical problems in practice;
  • select and evaluate the appropriate procedure for isolating the active substance from the medicinal product, active substance, and/or metabolite from biological material;
  • perform quality control of individually and batch-prepared medicinal products according to the pharmacopoeia or other standards;
  • define factors affecting the stability of pharmaceuticals and propose measures to improve the stability;
  • explain the significance of individual stability tests;
  • propose the design of a stability study.
Last update: Kučera Radim, doc. PharmDr., Ph.D. (30.09.2025)
 
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