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Abstract

RP-HPLC ANALYSIS FOR SIMULTANEOUS DETERMINATION OF RABEPRAZOLE SODIUM AND DOMPERIDONE FROM TABLET AND BULK DRUG BY INTERNAL STANDARD METHOD

Seema A. Gosavi*, Rasika D Bhalke, Girija B. Bhavar, Atul A. Shirkhedkar, Sanjay J. Surana

A specific and sensitive high-performance liquid chromatographic method for the simultaneous determination of rabeprazole sodium and domperidone in bulk drug and capsules was developed. Ranitidine hydrochloride was used as an internal standard. Separation of the drugs was carried out on the Luna C18 (5μ, 250 mm X 4.60 mm i.d.) at ambient temperature using a mobile phase consisting of ammonium acetate buffer pH 7.4 and acetonitrile (60:40 v/v). Flow rate was 1.0 ml/min with an average operating pressure of 158 kg/cm2. Quantitation was achieved with UV detection at 286 nm based on peak area with linear calibration curves at concentration ranges 10-50 μg/ml and 15-75 μg/ml for rabeprazole and domperidone, respectively. The method has been successively applied to pharmaceutical formulation. No chromatographic interference from the capsule excipients was found. The method was validated in terms of precision, robustness, recovery and limit of detection and quantitation.


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