Selective and validated spectrophotometric methods for the determination of nicorandil in pharmaceutical formulations
Journal Title: The AAPS Journal - Year 2004, Vol 6, Issue 4
Abstract
Two simple and sensitive validated spectrophotometric methods have been described for the assay of nicorandil in drug formulations. Method A is based on the reaction of the drug with phloroglucinol-sulfanilic acid reagent in sulfuric acid medium to give yellow-colored product, which absorbs maximally at 425 nm. Method B uses the oxidative coupling of 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) with DL-3,4-dihydroxyphenylalanine (DL-dopa) in the presence of nicorandil as oxidant in sulfuric acid medium to form an intensely colored product having maximum absorbance at 530 nm. Beer's law is obeyed in the concentration range 2.5 to 50.0 and 1.0 to 15.0 μg mL−1 with methods A and B, respectively. Both methods have been successfully applied for the analysis of drug in pharmaceutical formulations. The reliability and the performance of the proposed methods are established by point and interval hypothesis and through recovery studies. The experimental true bias of all samples is smaller than ±2%.
Authors and Affiliations
Nafisur Rahman, Yasmin Ahmad, Syed Najmul Hejaz Azmi
Keywords
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- EP ID EP681940
- DOI 10.1208/aapsj060434
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