Green analytical methods for isosorbide dinitrate determination by UV spectrophotometry and stability indicating HPLC-PDA

Abstract

Two analytical methods, green chemistry based, were developed, validated and compared for quantification of isosorbide dinitrate (ISDN) in sublingual tablets. The UV spectrophotometric method proved to be innovator and was carried out at maximum absorption of 205 nm using water as solvent. The HPLC method was stability indicating type, and ISDN was separated of its degradation products with a mobile phase consisting of methanol: water (50:50, v.v-1), in a flow rate of 1.0 mL.min-1 at room temperature. The forced degradation studies demonstrated the molecule intrinsic stability, which was unstable in hydrolysis and basic photolysis, oxidative medium and heat. In validation, the methods presented correlation coefficients greater than 0.99. The precisions were less than 3%. Both methods were robust for parameters tested and the accuracy values were found suitable. Statistical analysis proved that both methodologies are appropriate for ISDN quantification in quality control routine. The methods were considered simple, accessible, and economical and involved the use of reagents that are harmless to environment, to analysts and to components of the equipment, positive aspects that differentiate these methods from compendia and existing procedures in scientific literature. In addition, this article provides analytical methods both in developed industries and laboratories and in those with a structure still under development, what contributes to the reduction of health risk related to the quality of medicines. Keywords: