2018 - How to Develop Stability Indicating HPLC Methods

This course will enable you to understand how HPLC methods work, how to develop a new HPLC method, and how to show that a new or existing HPLC method (e.g. a pharmacopoeial method) is stability indicating.
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 measureable 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 two day training course is designed to provide a thorough understanding of how to develop HPLC methods specifically designed for stability indicating analysis of pharmaceuticals. 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. The same strategies may be applied to existing methods to demonstrate that they are stability indicating. The course is ideal for those who have some experience of using HPLC.
This course focuses on reversed phase mode separations.
Learning Objectives:
1. Define the objectives for the development of a stability indicating HPLC analytical method.
2. Effectively assess all the available relevant information relating to the desired method.
3. Perform forced degradation studies to prepare samples that will be used for the method development.
4. Select suitable scouting conditions to find a suitable column and mobile phase system and investigate stressed samples.
5. Optimise the chromatographic conditions to result in the best possible separation.
Use of case studies and real life scenarios:
Case studies are employed to allow consideration of real life scenarios. Delegates are invited to bring along any real life examples that they would like advice on during the training. These may be discussed during group exercises, or, where intellectual property is an issue, privately with the trainer.
This course is suitable for:
Anyone who has some experience of using HPLC and wants to know more about how HPLC methods work, and how to develop new HPLC methods, particularly for stability indicating purposes.
For example:
•Analytical chemists;
•Laboratory managers/ supervisors;
•Quality control analysts/ managers,etc.
Included in the course fees:
• Comprehensive course hand-outs;
• Certificate of Attendance;
• Access to training resources via e-MTS;
• Optional post training assessment (leading to Certificate of Training);
• Post training support;
• Lunch and refreshments (for open-enrolment courses only).