Abstract

Prof. Manasa Merugu* and Ratnakar Nathi

ABSTRACT

A specific, accurate, precise and reproducible stability indicating HPLC method has been developed and subsequently validated for Domperidone in commercial tablets. The proposed HPLC method utilizes Agient eclipse XDB C18 column (150 mm - 4.6 mm i.e., 5 ?m) and mobile phase consisting of methanol-Water(50:50, v/v) at a flow rate of 1.0 mL/min. Quantitation was achieved with UV detection at 270 nm based on peak area with linear calibration curves at concentration range 12.5-200.0?g/mL for Domperidone (R2 > 0.999). The method was validated in terms of accuracy (% recovery 99.6%), precision (%RSD 0.04), linearity, limits of detection (4.1 ng/ml), limits of quantitation (12.6ng/ml), assay (100.5%), and robustness. This method has been successively applied to pharmaceutical formulation and no interference from the tablet excipients was found Domperidone drug product were exposed to acid, base and neutral hydrolysis, oxidation, dry heat and photolytic 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.