Modernization of USP and Ph. Eur. method – Irbesartan organic impurities/related substances

In this application note, Phenomenex demonstrates the potential method improvements that can be achieved within the defined allowable adjustments of chromatographic conditions per the USP and Ph. Eur. monographs using Luna^™ C18(2) and Kinetex^™ C18 columns. Irbesartan is a potent selective angiotensin II type 1 (AT1) receptor antagonist and is used in the treatment of hypertensive patients and diabetic nephropathy. This study for irbesartan and its related substances is based on USP and Ph. Eur monographs where an L1 (USP) or end-capped octadecylsilyl silica gel (Ph. Eur.) stationary phase is used under isocratic conditions.