Otimização e validação de método analítico por CLAE para quantificação de dinitrato de isossorbida matéria-prima, comprimidos simples e sublingual

Abstract

A selective, simple and low cost effective high performance liquid chromatography (HPLC) method was developed and enhanced for quantification of isosorbide dinitrate (IDN), a drug of the class of nitrates used as a vasodilator in angina pectoris, for analysis of raw material, simple and sublingual tablets. In the optimization of the method it sought to obtain suitable chromatographic conditions using lower concentrations of buffer, eliminating internal standard and with a fast sample preparation, resulting in the use of Phenomenex® C18 Luna (150 x 4.6 mm, 5 μm) column, mobile phase constituted of 4 mM ammonium acetate buffer pH 4.7 and methanol (50:50, v/v), flow rate of 1.0 mL min-1, injection volume of 20 μl, detection at 210 nm and retention time about 5.7 min. The new HPLC method developed in this work was successfully validated demonstrating to be specific, precise, accurate, robust and linear in the desired concentration range of 50 - 150 μg mL-1. Therefore, this method can be used on quality control for quantitative analysis of IDN in commercially available raw material, simple and sublingual tablets.