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Course Programme

Analytical method development - Part 1
  • Theory and factors affecting resolution - a reminder of the importance of resolution, separation factor (selectivity), retention factor (capacity factor) and column efficiency)
  • Selecting the HPLC separation mode (reversed-phase, normal-phase etc.)
  • Overview of instrumentation
  • Selecting the most appropriate detector
  • Troubleshooting

Workshop: Selecting the separation mode

Analytical method development - Part 2
  • Gradient/isocratic operation appropriate?
  • Selecting the column for analysis
  • Selecting and optimising the mobile phase
  • The effect of pH, considering pKa of the analyte

Workshop: Selecting the column and mobile phase

Developing stability-indicating methods
  • Requirements for a stability-indicating analytical method
  • Anticipation of likely degradation products:
    • From experience with compound
    • From forced degradation (stress testing) of drug substance, as per ICH guidance
    • Note findings of stress-testing industry comparison
    • Are degradation products likely to be enantiomers or diastereoisomers?
  • Calculation of mass balance and its significance

Workshop: Developing stability-indicating methods

Validation of chromatographic methods
  • A detailed discussion on the parameters to be validated:
    • Specificity: peak purity determination (Diode array)
    • Linearity
    • Range
    • Accuracy
    • Precision
    • Detection Limit
    • Quantitation Limit
    • Robustness
  • Extent of validation: how much work at each phase of development?
  • Acceptance criteria
  • Validation procedures and protocols
  • Dealing with validation failures
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