A RP-HPLC METHOD DEVELOPMENT FOR THE ESTIMATION OF RIZATRIPTAN BENZOATE FROM FORMULATED FAST DISINTEGRATING SUBLINGUAL TABLETS

ABSTRACT: A simple, accurate, precise RP-HPLC method has been developed for the estimation of Rizatriptan Benzoate. Good chromatographic separation was achieved by isocratic mode with Sodium dihydrogen orthophosphate as buffer (pH 3.5): Acetonitrile (80:20), as the mobile phase with Zorbax SB phenyl column (250 x 4.6 mm i.d, 5 µ particle size) as stationary phase with a flow rate of 1.0 ml/min at ambient temperature. Quantification was attained with UV detection at a wavelength of 255 nm. The retention time for Benzoate and Rizatriptan was 3.85 minutes and 4.32 minutes respectively. The calibration graphs were linear in the concentration range of 5 – 25 μg/ml. The developed method was effectively applied to formulated fast disintegrated sublingual tablets of Rizatriptan Benzoate and the % assay of the drug was found to be 96.4%. This method was statistically validated for the determination of accuracy, precision, specificity, linearity, range, limit of detection, limit of quantification and system suitability according to ICH guidelines