Development and validation of a reversed-phase ion-pair high-performance liquid chromatographic method for the determination of risedronate in ... [An article from: Analytica Chimica Acta]

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Description:
A stability indicating, reversed-phase ion-pair high-performance liquid chromatographic method was developed and validated for the determination of risedronate in pharmaceutical dosage forms. The determination was performed on a BDS C"1"8 analytical column (250mmx4.6mm i.d., 5@mm particle size); the mobile phase consisted of 0.005M tetrabutylammonium hydroxide and 0.005M pyrophosphate sodium (pH 7.0) mixed with acetonitrile in a ratio (78:22, v/v) and pumped at a flow rate 1.00mLmin^-^1. The ultraviolet (UV) detector was operated at 262nm. The retention times of magnesium ascorbyl phosphate, which was used as internal standard and risedronate were 4.94 and 5.95min, respectively. The calibration graph was ranged from 2.50 to 20.00@mgmL^-^1, while detection and quantitation limits were found to be 0.48 and 1.61@mgmL^-^1, respectively. The intra- and inter-day percentage relative standard deviations, %R.S.D., were less than 5.9%, while the relative percentage error, %E"r, was less than 0.4%. The method was applied to the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control.