Ranitidine hydrochloride: development of an isocratic stability-indicatinghigh-performance liquid chromatographic separation

The development of a stability-indicating assay for ranitidine hydrochlorid e using a mobile phase added ion-interaction reagent was achieved. The assa y easily separated all known and unknown impurities/degradants. This assay may be used for the determination of purity, identity and strength for the active ingredient and finished dosage forms. Placebo samples were analyzed for all of the dosage forms and did not interfere with the separation. The system was found to be linear over a range of 0.056 to 44.4 mug/g, with a L imit of detection of 0.028 mug/g and a limit of quantitation of 0.056 mug/g . The system precision was determined to be 0.7%. The development of the st ability-indicating assay and the effect that each chromatographic variable had on the separation will be discussed. (C) 2001 Elsevier Science B.V. All rights reserved.