ZOOM Online: Development of Stability-Indicating HPLC Methods

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Stability testing is an essential part of drug development which ensures the quality, safety and efficacy of the drug for the lifetime of the drug product.

Appropriate storage conditions can only be assessed once a stability study has been conducted and it is never too early to start gathering stability data. Stability studies are a pharmacopoeial requirement and guidance is provided by regulatory authorities, including ICH.

This course provides a comprehensive review of the considerations relevant to developing a stability-indicating analytical method, principally focussing on analysis by HPLC. This course starts by anticipating likely degradation based on chemical structure. Consideration is then given to forced degradation (stress study) to produce likely degradants, followed by the selection of an HPLC method which is capable of resolving any degradants that have been formed.

Upon completion of this course, delegates will have learned what is necessary to develop a stability-indicating method for drug substance and drug product to comply with international regulatory guidelines.

Overview of developing a stability-indicating method

  • Regulatory framework
  • What can go wrong on storage”
  • Real-time, accelerated and forced degradation
  • Chemical and photochemical decomposition
  • Requirements for a stability-indicating analytical method
  • Stress testing objectives
  • Anticipation of likely degradation products
  • Common degradation pathways
  • Chiral degradation products

Workshop: Anticipation of likely degradation products

  • Forced degradation (stress testing) of drug substance, as per ICH guidance
  • How much degradation is enough” When do we stop”
  • Typical stress testing approaches, including Accelerated Stability Assessment Program (ASAP)

HPLC Methods

  • Brief overview of HPLC theory
  • Common modes of HPLC: Reversed and normal phase HPLC
  • Different approaches to stability analysis using HPLC * Determination of degradants and HPLC assay calculation
  • Mass balance

Essentials of the stability-indicating HPLC method

  • Is the method doing everything I need”

Workshop: Selecting the Separation Mode for a Stability Indicating HPLC Method and Consideration of Detection Issues

Group discussion

Mark Powell - Analytical Services (Dissolution Testing, QbD, HPLC)

Mark Powell - Analytical Services (Dissolution Testing, QbD, HPLC)

Mark is a Fellow of the Royal Society of Chemistry with over thirty years' experience as a senior analytical chemist. He taught pharmaceutical analysis at the Liverpool John Moores University School of Pharmacy and Chemistry from 1997 to 2003 and was also active in research.

In 2003, he joined the newly-formed Quay Pharmaceuticals, a contract research and manufacturing organisation specialising in early-stage drug development, where he was responsible

for analytical development. Since 2010, as Quay"s Scientific Manager, Mark was involved more generally with drug development programmes and also established collaborations with a number of UK universities and instrument manufacturers. His work at Quay has resulted in a number of published papers and presentations at scientific conferences.

In 2013 Mark set up his own consultancy company and has since worked

for clients all over the world on both early-stage and late-stage drug

development projects. He has particular expertise in dissolution method development and chromatography, and is in demand as a trainer in topics ranging from pharmaceutical analysis to data integrity and technical report writing.

Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster. Scientists who have to validate HPLC methods in accordance with current internationally-accepted guidance. HPLC technicians working in R&D laboratories, quality control laboratories and stability testing laboratories. Managers with a responsibility for generating regulatory submissions.


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