Principles of HPLC Validation


Although the focus is on pharmaceuticals, the principles apply for most quantitative HPLC methods, such as environmental or general chemical analyses.

This course is designed for laboratory personnel responsible for validating HPLC methods. It will also be useful for managers and quality assurance staff involved in the method validation process. For workers who develop, but do not validate methods, this class will give insight into how to develop methods that will be easier to validate. No prior experience is needed, although those with some laboratory experience will certainly benefit more than those with no experience at all.

Here’s what the course covers:

  • What the steps are that need to be undertaken during validation
  • Why quality is so important
  • What basic chromatographic measurements will be used
  • Why to approach validation as part of a larger process
  • Which regulatory documents are important
  • What parameters of the method need to be tested
  • What are the different standardization techniques, and when are they used
  • What is Quality by Design, and why is it important
  • What software tools are available to simplify the process
  • What pitfalls should be avoided in validation
  • What is pre-validation, and why is it worth my time
  • How do I choose a system suitability sample
  • How can I tell if the method is out of control
  • How much can I adjust a method before I have to re-validate

User licence:

  • Unlimited individual course access for a 12-month (365-day) period
  • ‘Certificate of Completion’ once all modules of a course have been completed and all quiz questions answered correctly (don’t worry, you can attempt the questions as many times as you like)
  • Tailor-made pricing or site licences** are also available (see below for further information)

Check out our FAQ to answer commonly asked questions:

Online payment for the course is via credit card (Stripe). Alternatively, if you would like to be invoiced directly, please contact us:

We offer tailor-made pricing to individual users who are interested to access up to three multiple courses, please contact us:

To find out more visit our course library:

  • One Individual Course – USD975/year
  • Two Individual Courses – USD1,380/year
  • All GC Courses – USD1,500/year
    (Introduction to GC, Intermediate GC, GC-MS for Operators & Developers)
  • All LC Courses – USD2,000/year
    (Fundamentals of HPLC, HPLC & UHPLC Troubleshooting, Advanced HPLC Method Development, LC-MS/MS for Chromatographers, HPLC for Biopharmaceuticals, Principles of HPLC Validation)
  • All LC and GC Courses – USD3,000/year


  • Instant access: users who sign up for an individual course and pay with a credit card via our shop, will get immediate course access.
  • Manual account set-up: those who sign up for multiple individual courses, site licences, the ‘Interpretation of Mass Spectra’ course or those individual users who asked to be billed directly, will be contacted via email to help set up your course access.

Analytical Training Solutions, brought to you by Separation Science (, is the leading global portal for fundamentals, best practice, troubleshooting and method development training for chromatographic and mass spectrometric techniques. Comprehensive, self-paced online courses and validated learning provides a unique educational resource for analytical chemists. Currently, we offer HPLC training, LC-MS training, GC training and GC-MS training.