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There is a quota of 25 for the unit. For this reason, Medicinal Chemistry students taking the unit as an elective need to contact the faculty directly to be placed on a waiting list for enrolment into the unit.
This unit aims to provide students with applied "job-ready" analytical competencies and allows students to develop skills in analytical method development and validation especially in the context of HPLC. This unit is taught according to a Problem Based Learning method in order to further enhance the "job- readiness" aspect of the learning. A real case study of compounds separation comprising method development and method validation is proposed and needs to be conducted in a Good Laboratory Practices standard.
At the end of this unit students will be able to:
- Correctly operate pipettes, pH meters, balances, conduct volumetric dilutions and filtration;
- Correctly label equipment, write, codify and understand the importance of GLP documentation;
- Organize to work in a student team constituted of a project manager, a QA manager and scientists responsible for the instrument, solutions preparation and software (roles rotate every week) as in Industry;
- Effectively operate HPLC instruments to conduct sample analysis, applying all components of the HPLC process, solution and sample preparation, HPLC set-up and operation and HPLC instrument software;
- Investigate and find information about the problem in available resources and identify the parameters that can solve the problem;
- Elaborate a plan, propose a series of experiments and predict the results that will solve the problem at hand and justify the prediction in a class presentation;
- Perform the experiments, compile the results between groups and critically analyze, interpret and conclude on the outcome;
- Understand, practically judge, and select correct capacity factor k' and efficiency N (optimum linear velocity- Van Deemter equation) to improve resolution and minimize band broadening;
- Select and combine the most effective solvent, columns and stationary phase chemistry, to improve selectivity and subsequently separation resolution;
- Differentiate between isocratic and gradient method benefits and develop a gradient method to shorten the run time of a separation while maintaining an acceptable resolution;
- Manipulate the HPLC software to accurately integrate a peak for accurate quantitative analysis;
- Understand principles of Method Validation (linearity, range, LOD LOQ, precisions, accuracy, reproducibility, robustness), recommend a plan of action and organize to elaborate a method validation protocol, generate and analyze validation data in an iterative process in order to pass acceptance criteria as articulated in ICH guidelines;
- Use a Plackett Burman Design of experiment template developed in PSC3201 to analyse and conclude about the robustness of the developed method as specified in ICH guidelines;
- Synthesize all the validation results and write a report which discusses the results and concludes on their adequacy with the validation acceptance criteria;
- Identify, understand and exploit for improvement the differences between HPLC and UHPLC;
- Troubleshoot common HPLC problems, maintain HPLC systems and columns.
Final exam (3 hours): 60%; Practical work: 30%; Workshop/discussions work: 10%.
PSC2031 Analytical methods (previously coded PSC2021)
PSC3201 Product development II