HPLC Method Development Incorporating Quality by Design

1 Day Course

HPLC method development training course incorporating a Quality by Design (QBD) approach. The course provides a step-by-step approach to all the crucial aspects of method development, including information gathering, mode of chromatography, development of mobile phase systems, column choice, principles of ionisation/suppression, optimisation of important chromatographic parameters (R, α, k’ and N), isocratic and gradient operation and detector choice and optimisation. Each aspect is discussed in detail with relevant examples used to demonstrate theoretical principles.

We recommend that course numbers are limited to 10 so that each delegate gets the opportunity to ask questions and fully participate in tutorial exercises
As the training is delivered on-site, we can design the course material to suit your specific needs
Customisable written assessments are available if required

Course Overview | Download course details »

This one day course provides a step-by step approach to method development for HPLC using Quality by Design (QBD) principles.

All sections are accompanied by participative tutorial exercises using interactive chromatgraphic modelling software simulations for increased understanding of critical concepts.

Who is this course for

This course is designed for the more experienced chromatographer with a good working knowledge of HPLC separations. Attendance of the Fundamental HPLC and HPLC Troubleshooting and Maintenance training courses is not compulsory but is advantageous.

Previous knowledge

Delegates should have a good knowledge of chromatography and experience as HPLC users. Some experience in method development is recommended. A good grounding in chemistry is also beneficial.

What you will learn

Setting method development objectives
Sample preparation
System choices
Choosing a column and mobile phase
Optimisation strategies
Quantitation and system characterisation

Course Outline

Introduction to QBD approach to method development

Combined resolution equation (k', N and alpha) with reference to practical method development process

Critical method parameters

Selectivity
Method robustness

Troubleshooting common problems relating to the sample

Mobile phase considerations

Ionisation, pH and pKa
Buffers - role, types and molarity
Flowrates
Organic modifier

Choosing a Column

Physical dimensions (length, ID, pore size)
Particle size, particle type, UHPLC
Temperature
Endcapping
Bonded silica phases - pH and mobile phase restrictions
Reversed phase ligand chemistry
Column classification tests (Tanaka, PQRI, HSM etc.)

HILIC

Specificity, peak purity and detection

Gradient and isocratic elution

Prelimanary retention time scouting

Troubleshooting retention time issues

Second stage optimisation - optimising selectivity choices

Linearity, range and sensitivity

Methods of quantitative calibration

Pre-validation