Development and Validation of a stability indicating method for the simultaneous determination of Levosulpiride and Rabeprazole by High Performance Liquid Chromatography
Keywords:Levosulpiride, Rabeprazole, HPLC, Proton Pump Inhibitors, Dopaminergic antagonist
A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of Levosulpiride and Rabeprazole in pharmaceutical Tablet dosage form. The mobile phase consisted of 60:40 % (v/v) of Methanol & 0.1% v/v orthophosphoric acid operated on isocratic mode. The flow rate is 1.0 ml/min. Chromatographic separation of Levosulpiride and Rabeprazole was performed on AGILENT POLARIS C18 column (150 X 4.6 mm id, ODS 2, 5?m). The wavelength of detection is 232 nm. The injection volume is 20?L. The retention time of Levosulpiride and Rabeprazole are 2.1 ± 0.10 minutes and 4.1 ± 0.10 respectively. The run time of analysis is 6 minutes. The developed method was validated for parameters such as accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The influence of acid, alkaline, oxidative Stress and photolytic stress conditions on both the drugs was studied. Results indicated complete degradation in alkaline medium for Levosulpiride and Rabeprazole. The proposed method has been successfully used for the estimation in tablet dosage forms.
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