Pharmaceutical Analysis FSE

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)

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.