Chromatographic methods for determining the identity, strength and purity of ranitidine hydrochloride both in the drug substance and its dosage forms--an exercise in method selection, development, definition and validation.

The selection, development, definition and validation of selective stability-indicating procedures for high-performance liquid chromatographic and thin-layer chromatographic analyses of ranitidine hydrochloride are described. The procedures used in conjunction can be applied to the quality assurance and stability assessments of both the drug substance and its dosage forms and serve to establish the identity, strength and purity of this drug used in the treatment of peptic ulcer and related conditions.