To develop separation and extraction strategies in the analysis of drugs in pharmaceutical preparations
Learning Outcomes
On successful completion of this module the learner will be able to:
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Learning Outcome Description
LO1
Develop spectroscopic and other methods in the principles of validation of an analytical method.
LO2
Validate the major extraction and separation techniques used in sample recovery
LO3
Explore the assay methods to determine contaminant degradation by-products using standard chromatographic techniques
LO4
Evaluate the methods used in the analysis of various drug delivery vehicles
Dependencies
Module Recommendations
This is prior learning (or a practical skill) that is recommended before enrolment in this module.
No recommendations listed
Co-requisite Modules
No Co-requisite modules listed
Additional Requisite Information
No Co Requisites listed
Indicative Content
Assay Development
• Discuss the principles of validation of an analytical method.
• Evaluate the major extraction and separation techniques used in sample recovery
• Develop assay methods separating out drug and primary metabolites using standard chromatographic methods
• Explore the robustness of the methods in the analysis of sustained-release, multi-dose and other drug-delivery forms
Module Content & Assessment
Assessment Breakdown
%
Continuous Assessment
10.00%
Practical
30.00%
End of Module Formal Examination
60.00%
Assessments
Full Time
Continuous Assessment
Assessment Type
Case Studies
% of Total Mark
10
Timing
n/a
Learning Outcomes
1,4
Non-marked
No
Assessment Description Regular written examinations to evaluate student understanding of course content
Exam Board It is at the discretion of the Examination Board as to what the qualifying criteria are.
SETU Carlow Campus reserves the right to alter the nature and timings of assessment
Module Workload
Workload: Full Time
Workload Type
Workload Category
Contact Type
Workload Description
Frequency
Average Weekly Learner Workload
Hours
Lecture
Contact
Assay/Analytical Method Development
12 Weeks per Stage
3.00
36
Practicals
Contact
Practical extractions followed by analytical determination.
12 Weeks per Stage
6.00
72
Independent Learning
Non Contact
Study best assay development methods
15 Weeks per Stage
9.47
142
Total Weekly Contact Hours
9.00
Module Resources
Recommended Book Resources
A. B. Lyons. (2017), Practical Standardization by Chemical Assay of Organic Drugs and Galenicals, 1st. Forgotten Books, [ISBN: 978-048428632].
S. Mathew. (2012), Analytical Method Development by HPLC For Starters, Kindle.
C.M Riley, T.W. Rosanske. (2018), Specification of Drug Substances and Products: Development and Validation of Analytical Methods, 1st. Elsevier, [ISBN: 978-00810131].
This module does not have any article/paper resources