Analytical Method Development and Validation for Estimation of Dexrabeprazole and Domperidone in Bulk and Tablet Dosage Form by RP-HPLC

Abstract:

This study presents the development and validation of an analytical method for the simultaneous estimation of Dexrabeprazole and Domperidone in bulk and tablet dosage forms using Reverse Phase High-Performance liquid chromatography (RP-HPLC). The method was optimized and validated to ensure its accuracy, precision, and reliability. A Waters HPLC system with an auto- sampler and PDA detector (model 996) was utilized for the analysis. The chromatographic separation was achieved using an Altima C18 (4.6 *150 mm,5μm) with a mobile phase composed of methanol and acetone in a ratio of 65:35 (v/v). The flow rate was set at 1 ml/min, and detection was performed at a wavelength of 240 nm. The injection volume was 10 μl, and the total run time for the analysis was 14 min. The method demonstrated suitable performance in terms of resolution, peak shape, and retention time, making it a reliable approach quantification of dexrabeprazole and domperidone in both bulk and tablet formulations. The developed method complies with the regulatory requirements for analytical methods, ensuring its application in routine quality control and stability studies. Keywords: RP-HPLC, Dexrabeprazole, Domperidone, Simultaneous estimation, Method Development.

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