In the first part of this series, an overview of the concept of method adjustment vs method change in reversed-phase HPLC is presented.
We all know that no HPLC method is perfect and that it may need to be “tweaked” once in a while to make it operate properly. But in today’s highly regulated environment, there’s always a question about whether or not such adjustments are allowed. For compendial methods in the pharmaceutical industry, the various pharmacopoeia give guidelines about method adjustment.
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