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Development and Validation of a Rapid RP HPLC Method for the Determination of Cinitapride Hydrogen Tartarate in Pure and its Pharmaceutical Formulation

Namrata Basnet, Syeda Humaira and Syed Sanaullah

A rapid, specific, reverse phase high performance liquid chromatography [RP-HPLC] method has been developed for assaying Cinitapride Hydrogen Tartarate (CHT) in pure and pharmaceutical formulations. The assay involved an gradient elution of CHT in a Symmetry C18 (4.6 × 150 mm) column using a mobile phase composition of acetonitrile and Phosphate buffer pH 2.5 (68 : 32). Detection was carried out by UV at 264 nm. The flow rate was 1 mL/min and the analyte monitored at 264 nm. The assay method was found to be linear from 10 to 60 μg/mL and met all specifications as per ICH guidelines. Statistical analysis revealed that this method can be used in routine quality control studies of Cinitapride Hydrogen Tartarate in pure and its formulations