How to Develop Stability Indicating HPLC Methods
Training
In City Of London, Dublin (Ireland) and Berlin (Germany)
Description
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Type
Training
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Level
Intermediate
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Location
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Class hours
7h
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Duration
2 Days
This 2 day training course is designed to provide a thorough understanding of how to develop HPLC methods specifically intended for stability indicating analysis of pharmaceuticals. The course will describe strategies for preforming forced degradation studies and selecting optimal HPLC method parameters to ensure that all relevant degradation products are separated.
Facilities
Location
Start date
Start date
Start date
Start date
About this course
Define the objectives for the development of a stability indicating HPLC method.
Effectively assess all available relevent information relating to the desired method.
preform 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.
Optomise the chromatagraphic conditions to result in the best possible separation.
This course is ideal for anyone with some knowledge of HPLC and wants to further their understanding of the subject
This course is ideal for those who have some experience of using HPLC.
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Teachers and trainers (1)
Oona McPolin
Training consultant
Training consultant specialising in analytical chemistry relating to pharmaceuticals; design and deliver training courses including validation and transfer of analytical methods and high performance liquid chromatography (HPLC). Analytical chemist with over 17 years' experience in pharmaceutical analysis; developing, validating and implementing analytical methods in process and formulation, stability, forced degradation, regulatory submissions. · Fully qualified award winning trainer in design and delivery of effective training for technical subjects.
Course programme
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.
Additional information
How to Develop Stability Indicating HPLC Methods