FAAL1_15 Analysis of Drugs

Farmaceutická fakulta
podzim 2024
Rozsah
2/3/0. 8 kr. Ukončení: zk.
Vyučováno prezenčně.
Vyučující
doc. PharmDr. Ing. Radka Opatřilová, Ph.D., MBA (přednášející)
doc. PharmDr. Ing. Radka Opatřilová, Ph.D., MBA (cvičící)
Mgr. Hana Pížová, Ph.D. (cvičící)
PharmDr. Bc. Lenka Coufalová, Ph.D. (cvičící)
Garance
doc. PharmDr. Ing. Radka Opatřilová, Ph.D., MBA
Ústav chemických léčiv – Ústavy – Farmaceutická fakulta
Předpoklady
FAKULTA ( FaF ) || OBOR ( MUSFaF )
Omezení zápisu do předmětu
Předmět je určen pouze studentům mateřských oborů.
Mateřské obory/plány
Cíle předmětu
Drug Analysis course aims to teach students to work methods and procedures used in the control practices for providing efficient, reliable and safe medicines.The subject is the interpretation of the principles of analysis - chemical and physico-chemical methods used in assessing individual indicators of quality (identity, purity, content, stability) of single chemically active substances, excipients and medicinal products.
Výstupy z učení
Learning outcomes of the course are theoretical knowledge and practical experience of students of methods used for comprehensive evaluation of drugs and medicinal products in accordance with applicable regulations in the Czech Republic and the EU. The content of the course is based on the requirements of the European Pharmacopoeia as a supranational legal norm. The graduate of the course Drug Analysis is to master the basic procedures and methods of pharmacopoeial evaluation of drugs. Evidence of drugs based on physical constants, using instrumental-analytical methods and chemical reactions. To control group and selective reactions of structural types of drugs within pharmacotherapeutic groups. He has mastered the technique of limit tests for the purity of drugs, volumetric and gravimetric determination of drugs and pharmaceutical excipients. He should be able to perform analytical evaluation of drugs and medicinal products using chromatographic, spectral and electroanalytical methods. He should be able to perform experimental studies of medicinal products, evaluation of relevant physical and chemical parameters, including detection and quantification of degradation products, according to the given procedure.
Osnova
  • LECTURES
  • Basic: Pharmacopeia
  • Purity and stability of drugs
  • Pharmacopoeial detection of impurities with the use of chemical reactions by means of physicochemical methods
  • Stability of drugs, processes of decomposition, factors influencing stability
  • Drug Identification
  • Detection of drugs by means of chemical reactions
  • Group and selective reactions of pharmacotherapeutic groups
  • Detection of drugs on the basis of physical constants (melting point, distillation range, density, refractive index, optical rotation)
  • Use of physicochemical methods for the detection of drugs (spectral, separational, electrochemical methods) Drug Assay
  • Volumetric methods used in drugs analysis
  • Acid-base titrations of drugs (acidimetry, alkalimetry in aqueous and nonaqueous media)
  • Oxidoreduction titrations of drugs (iodometry, bromatometry, manganometry, cerimetry)
  • Complexometric titrations of drugs (chelatometry, mercurimetry)
  • Determination of drugs by means of precipitation titrations
  • Spectrophotometric determination of drugs
  • Polarimetric determination of drugs
  • Determination of drugs with the use of electroanalytical methods
  • Determination of drugs by chromatographic and electrophoretic methods
  • PRACTICAL TRAINING
  • Control-analytical evaluation of drugs according to the Pharmacopoeia
  • Test for purity of drugs (chemical detection of impurities)
  • Test for purity of drugs (detection of impurities, or degradation products by chromatographic and spectral methods)
  • Identification of drugs by means of chemical reactions, physical constants, physicochemical methods
  • Determination of drug content (pharmacopoeial methods of quantitative evaluation of drugs)
  • Control-analytical evaluation of pharmaceutical preparations
  • Control of extemporaneously prepared pharmaceutical preparations according to the pharamacopoeia and control-analytical procedures used in drug control laboratories
  • Control of mass-produced pharmaceutical preparations according to factory standards (control- analytical methods used in outlet control in pharmaceutical industry)
  • Instrumental methods (use of UV spectrometry in drug control, control, analysis of drugs on the basis of specific optical rotation, analysis of drugs by means of HPLC and TLC)
Literatura
  • European Pharmacopoeia, 9th Edition. 2017. info
Výukové metody
lectures
Metody hodnocení
exam
Vyučovací jazyk
Angličtina
Další komentáře
Předmět je dovoleno ukončit i mimo zkouškové období.
Předmět je zařazen také v obdobích jaro 2020, podzim 2020, podzim 2021, podzim 2022, podzim 2023.