HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHIC-SEPARATION OF RANITIDINE HYDROCHLORIDE AND 2 RELATED-COMPOUNDS

Ranitidine hydrochloride and its two related compounds, used in the US P TLC purity testing of the drug, were separated on a high-performance thin-layer chromatography (HPTLC) RP-18 WF254S precoated plate using methanol-3% NH4OH (4:1, v/v) as the mobile phase. The main advantage o f the proposed HPTLC system over the USP TLC system for testing the pu rity of ranitidine is a better and more efficient separation of these three compounds in a shorter time and with less consumption of solvent s. The system is promising from the point of view of the development o f a new method for the TLC purity testing of ranitidine hydrochloride. A video system was used for imaging thin-layer chromatograms. Direct UV densitometric quantitation of the three compounds and a model for t he calculation of analytical performance parameters is presented in th e second part of the paper. (C) 1998 Elsevier Science BN. All rights r eserved.