Syllabus
Lectures
Identification of drugs on the basis of physical constants (melting temperature, distillation range, density, refractive index, optical rotation)
Use of physico-chemical methods for identification of drugs (spectral, separation and electrochemical methods)
Identification of drugs using chemical reactions
Group and selective reactions of individual structural types of drugs of important pharmacotherapeutical groups.
Pharmacopoeial detection of impurities using chemical reactions and physico-chemical methods
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 control-analytical method
Seminars & Practical training
Control-analytical evaluation of drugs according to the Pharmacopoeia
Identification of drugs using physico-chemical constants, chemical reactions, physico-chemical methods
Purity testing of drugs (chemical proofs of impurities, identification of 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.
As part of the Pharmaceutical Analysis I, students learn first the basic procedures and methods used for pharmacopoeial identity verification, purity assessment, and content determination of official pharmacopoeial substances. Besides the European Pharmacopoeia, students are further acquainted with other world-renowned pharmacopoeial monographs (USP, JP, BP).
Pharmaceutical Analysis II 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.