A specific, accurate, precise and reproducible stability indicating HPLC method has been developed and subsequently validated for the simultaneous determination of levosulpiride and pantoprazole in Dosage form. The proposed HPLC method utilizes hypersil (Thermo scientific) C18 column (250 mm × 4.6 mm id, 5 μm particle size), and mobile phase consisting of acetonitrile - 0.05M potassium dihydrogen phosphate buffer - 0.1% triethylamine in the ratio of 45:55:2.5 and pH adjusted to 4.0 with orthophosphoric acid at a flow rate of 1.0 ml/min. Quantitation was achieved with UV detection at 290 nm based on peak area with linear calibration curves at concentration ranges 7.5-22.5 μg/ml for levosulpiride and 4-12 μg/ml for pantoprazole. The retention time of levosulpiride and pantoprazole were found to be 3.37 min and 4.94 min respectively. The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation and robustness. This method has been successively applied to capsule dosage form and no interference from the excipients was found. Levosulpiride, pantoprazole and their capsule dosage form were exposed to acid, base, oxidation, dry heat and sunlight stress conditions and the stressed samples were analyzed by the proposed method. As the proposed method could effectively separate the drug from its degradation products, it can be employed as stability-indicating method for the determination of instability of these drugs in bulk and commercial pharmaceutical formulations.
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