OPTIMIZATION, VALIDATION AND APPLICATION OF A CAPILLARY ELECTROPHORESIS METHOD FOR THE DETERMINATION OF RANITIDINE HYDROCHLORIDE AND RELATED SUBSTANCES

Ranitidine hydrochloride is an H-2-antagonist which is widely prescrib ed for the treatment of peptic ulcers. The drug is marketed in a varie ty of dosage forms including tablets, syrups and injection solutions. A range of synthetic and degradative impurities of ranitidine are know n and currently, these impurities are routinely determined using thin- layer chromatography (TLC). Alternatively a high-performance liquid ch romatography (HPLC) method has also been employed in the assay of the pharmaceutical preparation. Unlike TLC, capillary electrophoresis (CE) offers the capability to quantify simultaneously both the active drug content and the levels of the related substances. The advantages of s implicity, selectivity, versatility and ease of use of CE offers a com plementary separation technique to the established methods of HPLC and TLC in the determination of ranitidine and its related substances. Th is work represents a comprehensive evaluation of the performance of a developed CE method in the determination of drug-related impurities in both drug substance and various pharmaceutical formulations. The data obtained clearly shows that the performance of an optimised CE method can be equivalent in terms of sensitivity and precision to that of a HPLC method employed for a similar purpose and offers better selectivi ty against TLC and HPLC. (C) 1998 Elsevier Science B.V.