A Systematic Approach using pH and Column Selectivity Waters has designed a method development approach and accompanying four-column kit to establish stability-indicating methods that provide:
step-by-step protocol
comprehensive applications book
reproducibility
chromatographic selectivity
column lifetime and sensitivity
The need to save method development time and improve accuracy is forcing today’s analytical chemists to look for better, faster ways to develop stability-indicating methods. Costly delays can be prevented by quickly establishing robust analytical methods that remain useful throughout the life of a drug product.
Benefits of the Waters approachSystematic steps
Reduce development time
Less than 1 week to complete work per compound
Common retention factors (k)*
Unique Selectivity
Maximize chances for best separation
Methods on “new generation” HPLC columns
Best peak shape
Excellent reproducibility
Run at low and high pH
Maximize selectivity differences
Work in pH zones that maximize robustness by running two pH units above or below the pka
Perform degradation studies
Challenge the method to ensure resolution of all potential impurities
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