A Stability-Indicating Thin-Layer Chromatographic and Densitometric Method for Determination of Nicorandil in Tablet Formulations

A thin layer chromatographic method with densitometric detection has been developed for determination of nicorandil, in the presence of its degradation products and impurities, in tablet formulations. Nicorandil tablet solution was subjected to stress tests under thermal, photolytic, hydrolytic, and oxidative conditions, to induce degradation of the drug. Nicorandil was separated from the degradation products on RP18 TLC plates by isocratic elution and was determined densitometrically. To assess the specificity of the method two dimensional chromatography was performed with a second mobile phase of different selectivity. Because no interference from degradation products was observed in the assay of nicorandil by the described method, it can be regarded as a stability-indicating method and can be used for analysis of stability study samples and routine quality-control samples.