2,4-Dinitrophenylhydrazine used for Spectrophotometric Determination of Amiodarone in Pure Form and Pharmaceutical Preparations

For the measurement of amiodarone in its pure form and in pharmaceutical dose preparations, a straightforward, quick, and extremely sensitive spectrophotometric approach was created and verified. The suggested analytical method is based on an oxidative coupling reaction in a very alkaline media between amiodarone and oxidized 2,4-dinitrophenylhydrazine (2,4-DNPH), which produces a persistent yellowish-green chromogenic product. Spectrophotometric measurements of the generated color’s intensity were made against a reagent blank at a maximum absorption wavelength of 622 nm. Reagent quantities, alkaline medium type and concentration, oxidant concentration, reaction time, temperature, and addition sequence were all carefully adjusted to maximize sensitivity and repeatability. With a high molar absorptivity of 2.32 × 10⁴ L·mol⁻¹·cm⁻¹, the technique demonstrated good sensitivity under ideal conditions and obeyed Beer–Lambert’s law over a concentration range of 1.5–30 µg·L⁻¹. It was discovered that the limits of detection (LOD) and quantification (LOQ) were 1.11 and 2.32 µg·L⁻¹, respectively. Recovery values of 99.87% and a relative standard deviation (RSD) of 1.75% attested to the developed method’s exceptional accuracy and precision. A stable reaction product was formed, as evidenced by the stoichiometric ratio of 1:1 between amiodarone and 2,4-DNPH. The method’s selectivity was confirmed by interference studies, which showed that typical pharmaceutical excipients and surfactants such glucose, lactose, starch, and acacia did not significantly alter the result. By determining the amount of amiodarone in commercial tablet formulations, the suggested method’s applicability was effectively confirmed, producing dependable and satisfactory results. The suggested spectrophotometric method is a useful and efficient substitute for more intricate and costly analytical techniques for routine quality control analysis of amiodarone in pharmaceutical laboratories because of its simplicity, affordability, quick response, and high sensitivity.