Faculty of Pharmacy and Pharmaceutical Sciences

Monash University

Undergraduate - Unit

This unit entry is for students who completed this unit in 2014 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

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 First semester 2014 (Day)
Coordinator(s)Dr Laurence Orlando


Note: This unit was previously coded PSC3202


This unit is taught using a problem based learning approach and aims to provide students with knowledge and skills in analytical method development and validation. Students will develop applied job-ready analytical competencies in the context of HPLC. The problem case study will develop skills in working according to Good Laboratory Practices (GLP) standards.


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

  1. Precisely operate standard laboratory equipment to conduct accurate volumetric dilutions and filtration
  2. Appropriately label equipment, design and codify GLP documentation
  3. Effectively operate an HPLC instrument
  4. Develop teamwork skills including group contracting, goal setting and project planning, decision making and conflict management
  5. Prepare a clear plan of action to solve a given problem and justify the experimental design
  6. Accurately perform the experiments, compile the results and critically analyse, interpret and theorize on the observed phenomena
  7. Select correct capacity factor (k') and efficiency (N) to improve resolution and minimise band broadening;
  8. Compare and select the most effective solvent, columns and stationary phase chemistry, to improve selectivity and subsequently separation resolution to finalise an efficient HPLC method
  9. Compare and contrast isocratic and gradient methods and develop a gradient method to optimise the run time
  10. Describe the principles of method validation and prepare a method validation protocol taking into account the ICH guidelines;
  11. Report on analysis, evaluation, interpretation and synthesis of validation results and draw conclusions on validation acceptance criteria.
  12. Develop a systematic approach for troubleshooting HPLC systems.


In-semester assessment 50% and final assessment 50%

Chief examiner(s)

Workload requirements

Contact hours for on-campus students:

  • Eight 2-hour workshops
  • Eight 2-hour student led seminars
  • Eight 4-hours of practical laboratories
  • Eight 1-hour feedback


PSC2031 Analytical methods

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