This course will enable you to understand how HPLC methods work, how to develop a new HPLC method, with consideration of the principles outlined in ICH Q14, and how to ensure and demonstrate that a new or existing HPLC method (e.g., a pharmacopoeia method) is stability indicating.
HPLC is a popular technique for monitoring the decrease in drug and corresponding increase in degradation products due to its separating abilities. However, the HPLC method must be developed carefully to ensure that degradation products are both separated and detected appropriately.
This training course is designed to provide a thorough understanding of how to develop HPLC methods specifically designed for stability indicating analysis of pharmaceuticals, following the principles outlined in ICH Q14. The course will describe strategies for performing forced degradation studies and selecting optimal HPLC method parameters to ensure that all relevant degradation products are separated, and that mass balance has been achieved.
The same strategies may be applied to existing methods to demonstrate that they are stability indicating.
This course focuses on reversed phase mode separations.
Course overview
Pharmaceuticals need to be assessed for stability to support the assigned shelf life. Therefore, when analysing stability samples obtained from these studies, analytical methods are required which are stability indicating, i.e., there is a measurable response which correlates with degradation (if present).HPLC is a popular technique for monitoring the decrease in drug and corresponding increase in degradation products due to its separating abilities. However, the HPLC method must be developed carefully to ensure that degradation products are both separated and detected appropriately.
This training course is designed to provide a thorough understanding of how to develop HPLC methods specifically designed for stability indicating analysis of pharmaceuticals, following the principles outlined in ICH Q14. The course will describe strategies for performing forced degradation studies and selecting optimal HPLC method parameters to ensure that all relevant degradation products are separated, and that mass balance has been achieved.
The same strategies may be applied to existing methods to demonstrate that they are stability indicating.
This course focuses on reversed phase mode separations.
Learning Objectives:
- Define the objectives for the development of a stability indicating HPLC analytical method.
- Effectively assess all the available relevant information relating to the desired method.
- Perform forced degradation studies to prepare samples that will be used for the method development.
- Select suitable scouting conditions to find a suitable column and mobile phase system for an investigation of stressed samples and an evaluation of mass balance.
- Optimise the chromatographic conditions to result in the best possible separation.Case studies are employed to allow consideration of real-life scenarios.
Delivery
Delivered as a 3 day ‘virtual’ live online training event which is delivered over a 6-hour period, from 9am to 3pm, including breaks, on days 1 and 2, and over a shorter period, from 9am to 12:15pm, including a short break, on day 3.
The time zone is BST (GMT+1)This course is suitable for anyone who has some experience of using HPLC and wants to know more about how HPLC methods work, and specifically how to develop new HPLC methods which are aimed at stability indicating capability.
For example:- Development/Quality Control (QC) analytical chemists
- Development/Quality Control (QC) managers/ supervisorsIncluded in the course fees:
