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Abstract

A Simple and Sensitive HPTLC Method For The Determination Of Content Uniformity Of Nicorandil Tablets

Author(s): C. N Patel, S. A Shah, I. S Rathod, S. S Savale

A simple, sensitive HPTLC method was developed for the analysis of nicorandil in its commercial single component tablet formulations (5 mg). The stationary phase was precoated silica gel 60 F254.The mobile phase used was a mixture of chloroform:methanol:ammonia, (9:1:0.1 v/v). Detection of the spots was carried out at 254 nm. The method was validated in terms of linearity (200 600 ng/spot), precision (intra-day variation:0.503 to 1.960%, inter-day variation:0.333 to 3.070%), accuracy (97.69 to 100.26%) and specificity. The limit of detection and limit of quantification for nicorandil were found to be 40 ng/spot and 200 ng/spot, respectively. The proposed method was successfully applied to determine nicorandil content of 10 individual tablet units of two market formulations, after extracting nicorandil with methanol. Both the formulations complied with the USP specifications (RSD less than or equal to 6%) of the content uniformity test. The proposed HPTLC method can analyse ten or more formulation units simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine analysis of nicorandil tablet formulations.