Optimisation, validation and application of a capillary electrophoresis method for the determination of ranitidine hydrochloride and related substances.

Ranitidine hydrochloride is an H2-antagonist which is widely prescribed for the treatment of peptic ulcers. The drug is marketed in a variety of dosage forms including tablets, syrups and injection solutions. A range of synthetic and degradative impurities of ranitidine are known and currently, these impurities are routinely determined using thin-layer chromatography (TLC). Alternatively a high-performance liquid chromatography (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 simplicity, selectivity, versatility and ease of use of CE offers a complementary separation technique to the established methods of HPLC and TLC in the determination of ranitidine and its related substances. This 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 selectivity against TLC and HPLC.