A simple, accurate, precise stability indicting RP-HPLC method was developed and validated for estimation of prucalopride in tablet dosage form. This RP-HPLC method had shown adequate separation for prucalopride from its degradation products. The separation was achieved on an Inertsil ODS-3V C18 (250 mm × 4.6 mm i.d., 5 µm particle size) with an isocratic mixture of 10 mM potassium dihydrogen phosphate (KH2PO4) buffer (pH 2.0):methanol (50:50). The mobile phase at a flow rate of 1.5 ml/min, Injection volume 50 µl and wavelength of detection was kept at 225 nm. The retention time for prucalopride was 4.736 min. The linearity of the proposed method was investigated in the range of 50-150 µg/ml for prucalopride. Correlation coefficient was 0.999. Forced degradation study was carried out on tablet dosage form as per ICH guideline and it was exposed to hydrolysis (acid and base hydrolysis), oxidative and thermal conditions to apply stress. Proposed method was validated as per ICH guidelines for specificity, linearity, accuracy, precision and robustness for estimation of prucalopride in commercially available pharmaceutical dosage form and results were found to be satisfactory. The developed and validated RP-HPLC method can be used successfully for marketed formulations.
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