Faculty of Pharmacy and Pharmaceutical Sciences

Monash University

Undergraduate - Unit

This unit entry is for students who completed this unit in 2013 only. For students planning to study the unit, please refer to the unit indexes in the the current edition of the Handbook. If you have any queries contact the managing faculty for your course or area of study.

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6 points, SCA Band 2, 0.125 EFTSL

To find units available for enrolment in the current year, you must make sure you use the indexes and browse unit tool in the current edition of the Handbook.

FacultyFaculty of Pharmacy and Pharmaceutical Sciences
OfferedParkville Second semester 2013 (Day)
Coordinator(s)Dr Laurence Orlando

Quota applies

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:

  1. Correctly operate pipettes, pH meters, balances, conduct volumetric dilutions and filtration;
  2. Correctly label equipment, write, codify and understand the importance of GLP documentation;
  3. 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;
  4. 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;
  5. Investigate and find information about the problem in available resources and identify the parameters that can solve the problem;
  6. 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;
  7. Perform the experiments, compile the results between groups and critically analyze, interpret and conclude on the outcome;
  8. 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;
  9. Select and combine the most effective solvent, columns and stationary phase chemistry, to improve selectivity and subsequently separation resolution;
  10. 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;
  11. Manipulate the HPLC software to accurately integrate a peak for accurate quantitative analysis;
  12. 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;
  13. 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;
  14. Synthesize all the validation results and write a report which discusses the results and concludes on their adequacy with the validation acceptance criteria;
  15. Identify, understand and exploit for improvement the differences between HPLC and UHPLC;
  16. Troubleshoot common HPLC problems, maintain HPLC systems and columns.


Final exam (3 hours): 60%; Practical work: 30%; Workshop/discussions work: 10%.

Chief examiner(s)

Contact hours

Contact hours for on-campus students:
Eight 2-hour workshops
Eight 2-hour seminars
Eight 4-hours of practical laboratories
Eight 1-hour consultations


PSC2031 Analytical methods (previously coded PSC2021)
PSC3201 Product development II

Additional information on this unit is available from the faculty at: