Modernization of USP and Ph. Eur. method - pantoprazole sodium sesquihydrate organic impurities

In this application note, the fully porous Luna^™ 5 µm C18, 125 x 4.0 mm column was used for the analysis of pantoprazole. Further, modernization of this method was carried out on a fully porous, thermally modified, Luna Omega 3 µm C18, 100 x 3.0 mm column and a fully porous organo-silica Gemini^™ 3 µm NX-C18, 100 x 3 mm column. Pantoprazole is a proton pump inhibitor used for the treatment of stomach ulcers and short-term treatment of erosive esophagitis due to gastroesophageal reflux disease (GERD). This study shows the effective separation of pantoprazole from its organic impurities and related substances according to Ph. Eur. Monograph 2296 and USP Monograph for Pantoprazole Sodium Sesquihydrate Organic Impurities Test 2.