Analysis of Irbesartan - an Example of Scaling USP Methods

In this application note, the Irbesartan USP method is used as an example when transferring an HPLC method from one column dimension to another, from one sorbent particle size to another, or from one type of HPLC instrumentation to another. Four different conditions were evaluated, two within allowed changes, and two that would require complete revalidation (using a too short column, with too small particle size and not scaling the linear velocity accordingly).