SubjectsSubjects(version: 964)
Course, academic year 2024/2025
   Login via CAS
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
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 2024/25 Pharmacy (EN19)
Pre-requisite : GAF301, GAF302
Interchangeability : GAF186
Is co-requisite for: GAF322, GAF502
Is pre-requisite for: 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. (02.09.2024)
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. (02.09.2024)
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: prepocet_literatura.php (19.09.2024)
Teaching methods -

Lectures, seminars and practical training

Last update: Kučera Radim, doc. PharmDr., Ph.D. (02.09.2024)
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. (02.09.2024)
 
Charles University | Information system of Charles University | http://www.cuni.cz/UKEN-329.html