How to Develop Stability Indicating HPLC Methods
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:
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 and investigate stressed samples.
Optimise the chromatographic conditions to result in the best possible separation.
Open-enrolment training courses:
You can attend one of our open enrolment training courses at the following locations:
Hilton Garden Inn Heathrow, London, UK;
Metro Hotel Dublin Airport, Dublin, Ireland; and
GLS Campus Berlin, Germany.
The courses are available throughout the year, refer to the MTS website for full details.
On-site training courses:
We can deliver the course at your site including any required customisation to meet your specific requirements. Contact us to discuss your training needs and for a quotation.
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).
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:
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 and investigate stressed samples.
Optimise the chromatographic conditions to result in the best possible separation.
Open-enrolment training courses:
You can attend one of our open enrolment training courses at the following locations:
Hilton Garden Inn Heathrow, London, UK;
Metro Hotel Dublin Airport, Dublin, Ireland; and
GLS Campus Berlin, Germany.
The courses are available throughout the year, refer to the MTS website for full details.
On-site training courses:
We can deliver the course at your site including any required customisation to meet your specific requirements. Contact us to discuss your training needs and for a quotation.
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).
