A sensitive spectrofluorimetric method for the determination of ranitidine hydrochloride in pharmaceutical preparation

Abstract

A simple, precise and sensitive spectrofluorimetric method was developed and validated for the determination of ranitidine in pharmaceutical preparations. The method is based on derivatization of ranitidine with 4-fluoro-7-nitrobenzofurazan (NBD-F). The method was successfully validated in accordance to ICH guidelines. The validation characteristics included linearity, limit of detection, limit of quantification, accuracy, precision, specificity and robustness. The method is linear over the range of 40-1200 ng/mL. The recoveries were ranged from 98.97 to 99.43%. The proposed method was applied for the determination of ranitidine in commercially available tablets. The results were compared with those obtained by reference method using t and F-tests.