A SENSITIVE STABILITY-INDICATING ASSAY FOR THE H-2 BLOCKER RANITIDINE

A stability indicating high performance liquid chromatography assay for ranitidine has been developed for the study of ranitidine in intravenous solutions. The assay is based on an isocratic mobile phase, a C-18 reverse phase column, UV detection and utilizes an internal standard. The assay is shown to be accurate and precise over a range of ranitidine concentration commonly found in IV solutions. The mean inter- and intra-assay variability is low and retention times are stable. The assay separates ranitidine form ranitidine decomposition products produced at acidic and basic pH's.