Small Molecule Pharmaceuticals
Over the last decades, an increasing number of generic drug formulations have been released on the pharmaceutical market. These products are generally analyzed with compendia methods. This Application Note describes the method transfer of a USP HPLC method for amlodipine besylate tablets to a state-of-the-art UHPLC method. Adjustments on column dimension and method parameters were carried out within the permitted limits in order to avoid the need for a lengthy revalidation process. The Agilent 1290 Infinity II LC facilitated smooth transfer from one method to the other. System suitability criteria were investigated and met with both HPLC and UHPLC.
Publication number: 5991-6540EN
Publication Date: January 1, 2016