Pharmaceutical Analysis – Quality Assurance
| Title | Εφαρμοσμένη Φαρμακευτική Ανάλυση-Διασφάλιση Ποιότητας / Pharmaceutical Analysis – Quality Assurance |
| Code | ΠΜΣΒΦ-Μ5 |
| Faculty | Health Sciences |
| School | Pharmacy |
| Cycle / Level | 2nd / Postgraduate |
| Teaching Period | Winter/Spring |
| Coordinator | Aikaterini Markopoulou |
| Common | No |
| Status | Active |
| Course ID | 600023497 |
Programme of Study: P.M.S. Tmīmatos Farmakeutikīs "Viomīchanikī Farmakeutikī" (2023- )
Registered students: 30
| Orientation | Attendance Type | Semester | Year | ECTS |
|---|---|---|---|---|
| KORMOS | Compulsory Course | 2 | 1 | 8 |
| Academic Year | 2026 – 2027 |
| Class Period | Winter |
| Faculty Instructors | |
| Instructors from Other Categories | |
| Class ID | 600310064
|
Course Type 2021
General Foundation
Mode of Delivery
- Face to face
- Distance learning
Digital Course Content
- e-Study Guide https://qa.auth.gr/en/class/1/600310064
Language of Instruction
- Greek (Instruction, Examination)
- English (Instruction)
Learning Outcomes
The aim of the course is to provide the necessary knowledge on topics related to instrumental analytical techniques as they described in the International Pharmacopoeias and applied to the quality control of pharmaceutical products.
Through this course the postgraduate students will learn and improve their knowledge about the analytical techniques and methods of analysis for the characterization of pharmaceutical products.
General Competences
- Apply knowledge in practice
- Retrieve, analyse and synthesise data and information, with the use of necessary technologies
- Adapt to new situations
- Make decisions
- Work autonomously
- Work in teams
- Generate new research ideas
- Design and manage projects
Course Content (Syllabus)
• Instrumental separation techniques in Pharmaceutical Analysis.
• Theory of chromatography. Learning how to operate HPLC, (system suitability).
• Theory of Chromatographic columns
• Theory of Mass Spectrometry. Sample Cleanup, Extraction, Solid Phase Extraction (SPE)
• Chemical analysis of active substances in biological samples – Bioanalysis and sample pretreatment.
• Modern sample pretreatment techniques.
• Determination of active substance with ESI-LC / MS (positive / negative mode).
• Validation of analytical methods, objectives of method validation. Validation of analytical methods: objectives of method validation, how we can use the results of validation to set the right system suitability, forced degradation studies and how they contribute to validation, a new trend in validation of methods according to QbD guidelines
• Chemical analysis of pharmaceutical ingredients and raw materials
• Quantitative determination of two active ingredients in a pharmaceutical formulation by HPLC.
• Study of effect of solvent elution power, column temperature and flow rate on the separation of substances in HPLC.
• Determination of pharmaceutical substance content in a preparation by HPLC. Content uniformity control and statistical data processing of results.
• Determination of impurities of related structure of an active ingredient.
Educational Material Types
- Notes
- Slide presentations
Use of Information and Communication Technologies
Use of ICT
- Use of ICT in Course Teaching
- Use of ICT in Laboratory Teaching
- Use of ICT in Communication with Students
Course Organization
| Activities | Workload | ECTS | Individual | Teamwork | Erasmus |
|---|---|---|---|---|---|
| Lectures | 165 | ||||
| Laboratory Work | 15 | ||||
| Tutorial | 15 | ||||
| Exams | 8 | ||||
| Total | 203 |
Student Assessment
Student Assessment methods
- Written Exam with Multiple Choice Questions (Summative)
- Written Exam with Short Answer Questions (Summative)
- Written Exam with Extended Answer Questions (Summative)
- Written Assignment (Formative)
- Oral Exams (Formative)
- Written Exam with Problem Solving (Summative)
- Labortatory Assignment (Formative)
Last Update
28-02-2024
