Faculty of Pharmacy and Pharmaceutical Sciences

Monash University

Undergraduate - Unit

This unit entry is for students who completed this unit in 2012 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 0 (NATIONAL PRIORITY), 0.125 EFTSL

Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered, or view unit timetables.

FacultyFaculty of Pharmacy and Pharmaceutical Sciences
OfferedParkville Second semester 2012 (Day)
Coordinator(s)Dr Laurence Orlando


This unit aims to provide the student 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.

This will involve:

  • Essential analytical laboratory skills training
  • GLP documentation organisation
  • Team work organisation
  • HPLC theoretical principles
  • Knowledge of associated equipment
  • Applied HPLC method development
  • Applied HPLC method validation
  • HPLC troubleshooting


At the end of this unit students will be able to:

  1. Correctly use pipettes, pH meters, balances, conduct volumetric dilutions and filtration;
  2. Correctly label equipment, write and codify and understand the importance of GLP documentation;
  3. Organise and 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 use HPLC instruments to conduct analysis, applying all components of the HPLC process, solution and sample preparation, HPLC set-up and operation, HPLC instrument software;
  5. Understand and practically improve resolution by modifying capacity factor k', efficiency N (optimum linear velocity- Van Deemter equation), understand the concepts of band broadening and modify HPLC parameters to minimize it;
  6. Improve resolution by understanding and modifying selectivity using different columns and stationary phase chemistry;
  7. Understand the differences between isocratic and gradient methods, apply a gradient method to shorten the run time of a separation while maintaining an acceptable resolution;
  8. Manipulate the HPLC software to operate the HPLC system to accurately integrate a peak for quantitative analysis;
  9. Understand principles of Method Validation (linearity, range, LOD LOQ, precisions, accuracy, reproducibility, robustness), generate and analyse validation data in an iterative process in order to pass acceptance criteria as articulated in ICH guidelines;
  10. Use a Plackett Burman Design of experiment (developed by the students in PSC3201) to study the robustness of the developed method as specified in ICH guidelines;
  11. Identify, understand and exploit for improvement the differences between HPLC and UHPLC;
  12. Troubleshoot common HPLC problems, maintain HPLC systems and columns.


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

Chief examiner(s)

Dr Laurence Orlando
Dr Michelle McIntosh

Contact hours

16 hours of workshops, 16 hours of discussion, 32 hours of practicals. 6 hours per week of self-study is also expected.


PSC2021 Analytical methods
PSC3201 Product development II

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