Fast Stability Indicating UPLC Method for Quantitative Analysis of Dronedarone in Pharmaceutical Dosage Form: Force Degradation Study

Abstract

A simple, precise, rapid reproducible, selective, and stability indicating reverse phase UPLC method has been developed for the estimation of dronedarone in pharmaceutical dosage form. Estimation of dronedarone hydrochloride was achieved on Acquity BEH C 18 (100 mm * 2.1 mm) 1.7 m column using buffer [20 mM KH 2 PO 4 + 1 mL Triethylamine (pH = 2.5 by orthophosphoric acid)] and methanol in ratio of 40 : 60 as mobile phase at 30 ∘ C. The flow rate was 0.4 mL/min and effluents were monitored at 290 nm. The method was validated with respect to linearity, accuracy, precision, LOD, LOQ, and robustness. The method was linear over the concentration range 0.38-90 g/mL ( 2 = 0.999), with a limit of detection and quantification of 0.1 and 0.38 g/mL, respectively. Dronedarone was subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation, and photo (sunlight) degradation. The degraded product peaks were well resolved from the drug peak with significant difference in their retention time value.

Atomic Absorption Spectrophotometer – A Versatile Tool for the Estimation of Nickel Content in Dronedarone

“…It is a new active substance, and there is no official pharmacopoeial procedure available [6]. Literature overviews confess that drug was estimated by different analytical strategies such as spectrophotometric [7], highperformance liquid chromatography [8][9][10][11][12][13][14][15][16][17], and liquid chromatography mass spectrometry [18,19] in bulk drugs and formulation of dronedarone. From the review, it was found that there were no reported methods for the estimation of elemental impurity, i.e., nickel in dronedarone.…”

Ion Pair Colorimetric Estimation of Dronedrone HCl in Solid Dosages Using Methyl Orange

“…These derivatives were used mainly for the treatment of cardiac arrhythmias and also for the treatment of atrial fibrillation and atrial flutter [1][2][3][4][5][6][7] . The methods UV spectroscopic 8 , HPLC 9 , stability indicating HPLC [10][11][12][13][14] , HPTLC 15 for the estimation of dronedrone in bulk and formulations and LC-MSMS method for its estimation in biological matrics were reported 16 . Until now none of colorimetric methods have been reported for its estimation in bulk and pharmaceuticals.…”