PFT830 - Applied Pharmaceutical Analysis

Outline info
Last revision date 2017-11-21 10:50:09.998
Last review date 2017-11-21 10:50:17.408

Subject Title
Applied Pharmaceutical Analysis

Subject Description
Students learn the theoretical, practical and industrial applications of pharmaceutical compound analysis using various HPLC systems with a focus on UV absorbance detection. (Lectures and Labs)

Credit Status
One credit toward the Pharmaceutical Instrumentation Analyst (PIA) Certificate Program

Learning Outcomes
Upon successful completion of this subject the student will be able to:

1. Explain the basic theory and practice of HPLC.

2. Demonstrate basic HPLC system configurations.

3. Explain how to qualify, validate and calibrate an HPLC system to satisfy industry needs and standards.

4. Explain the practice of HPLC systems documentation regarding GLPs, SOPs, QA and QC, in the industrial environment.

5. Explain and demonstrate basic knowledge of compound chemistry, pharmacokinetics, analytical methods development and clinical trials/sample analysis.

Cheating and Plagiarism
Each student should be aware of the College's policy regarding Cheating and Plagiarism. Seneca's Academic Policy will be strictly enforced.

To support academic honesty at Seneca College, all work submitted by students may be reviewed for authenticity and originality, utilizing software tools and third party services. Please visit the Academic Honesty site on for further information regarding cheating and plagiarism policies and procedures.

All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at

Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Disabilities Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.

Strongly recommend students have Basic HPLC experience

Topic Outline

  • Introduction to Regulations and HPLC Technology, Industrial Application and the History of HPLC, HPLC System Hardware and Components, Lab Safety, WHMIS overview Lab: System Configuration and Start-Up Run and Evaluate Test Mixture
  • QC: Role and Function, HPLC in the QC Lab, Sample Preparation Methods and Techniques, Assessment of Analytical Methods, Integration, Quality Regulations Lab: Preparation and Run Test Samples Using a USP Method
  • WHMIS and Lab Safety, Standard Operating Procedures, Pharmaceutical Compounds and Chemical Detection Parameters, Introduction to Pharmacology and Pharmacokinetics (an overview) Lab: Standard Curve, Quantitation
  • Troubleshooting HPLC Systems, Validation, IQ, OQ, Instrument Repair Lab: Troubleshooting and Validation Routines
  • Data Analysis, Method Troubleshooting, Method Validation Lab: Multiple Compound Determination
  • HPLC Methods Development, Extraction, Validation, Bio- Sample Analysis, Bioequivalence/Availability, HPB Guidelines, GLP/GMP Regulations Lab: Sample Extraction and Analysis
  • Summaries, Discussion and Questions FINAL EVALUATION/ LAB EVALUATION

Mode of Instruction

  • Lecture
  • Laboratory
  • Group Problem Solving
  • Group Project Development

Prescribed Texts
None - Handouts 

Reference Material

  • L. Snyder, J. Glajch, J. Kirkland: Practical HPLC Method Development, (1988) Wiley
  • L. Snyder and J. Kirkland: Introduction to Modern Liquid Chromatography, Wiley ISBN: 978-0470167540
  • J.W. Dolan, L.R. Snyder: Troubleshooting LC Systems, (1989) Humana
  • LC/GC Magazine; Aster Publishing, Eugene, Oregon, USA

Required Supplies
Scientific Calculator

All students wear a laboratory coat and safety glasses while in the lab.  This requirement is mandatory and consistent with safe practice. 

Promotion Policy

Grading Policy
A+ 90%  to  100%
A 80%  to  89%
B+ 75%  to  79%
B 70%  to  74%
C+ 65%  to  69%
C 60%  to  64%
D+ 55%  to  59%
D 50%  to  54%
F 0%    to  49% (Not a Pass)
EXC Excellent
SAT Satisfactory
UNSAT Unsatisfactory

For further information, see a copy of the Academic Policy, available online ( or at Seneca's Registrar's Offices.

Modes of Evaluation

  • Assignments are due at the beginning of the class on which they are due.
  • A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
  • Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
  • Assignments are to be prepared by computer.

Absenteeism and Exams
  • Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
  • Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date.  Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence.  Examinations missed without official documentation and approval result in a grade of zero.
  • There are no deferred options for missed tests.  The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components

English Proficiency
  • All written work should demonstrate the following characteristics for clarity and conciseness:
-writing is consistent with the rules of English grammar
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.

Format for Assignments
  • Students must use the standard, APA style for quoting sources.   Help is available at:

Laboratory Attendance

The laboratory component is essential and therefore it is strongly recommended  that you attend all labs.  Any missed labs must be supported with a legal document with three days of the lab.  Any student who fails to attend 2 scheduled laboratory classes for a 7 week subject and more than 3 laboratory classes for a 14 week subject will not pass the subject.    

Laboratory Safety
Students are required to review and understand the safety procedures and guidelines outlined on the first class and sign the sheet to this effect before beginning work in the laboratory.  Students must also wear a lab coat and safety glasses when conducting experiments.
A student who arrives without the proper safety equipment will not be permitted to participant in the lab but will be asked to leave the class.  The student will receive no grade for the lab missed.

Grading is based on the following marking scheme:
Quiz after each lecture (6 each at 5%) 30%
Lab report after each lab session (6 each at 5%) 30%
Final Exam 40%

Other Evaluation Considerations
The student is expected to comply with the Safety Rules for working in the laboratory, sign the safety contract, and WILL NOT UNDER ANY CIRCUMSTANCES WEAR CONTACT LENSES in the laboratory.  The student will know where all safety equipment is located in the laboratory and will be familiar with WHMIS concepts and signage.


Approved by: Denis Gravelle