4
2014.
Development and Validation of HPLC Method for Determination of Pantoprazole in Pantoprazole Pellets
Since the assay method for pantoprazole in pantoprazole pellets is not described in current pharmacopoeias (USP, BP), the aim of this work was to develop and validate a simple, precise and accurate method for determination of pantoprazole in pantoprazole pellets. Separation was achieved on a reversed-phase C8 column (250 x 4.6 mm i.d.; 5 a mixture of phosphate buffer pH 3.0 and acetonitrile as mobile phase, at a flow rate 2 ml/min and UV detection at 290 nm. The method was validated according to ICH Guidelines. Validation showed that developed method was valid and reliable for determination of active substance in pantoprazole