Abstract
A simple, precise, and accurate HPLC method has been developed and validated for the quantitative analysis of Dronedarone Hydrochloride in tablet form. An isocratic separation was achieved using a Waters Symmetry C8 (100 × 4.6 mm), 5 μm particle size column with a flow rate of 1 ml/min and UV detector at 290 nm. The mobile phase consisted of buffer: methanol (40:60 v/v) (buffer: 50 mM KH2PO4 + 1 ml triethylamine in 1 liter water, pH=2.5 adjusted with ortho-phosphoric acid). The method was validated for specificity, linearity, precision, accuracy, robustness, and solution stability. The specificity of the method was determined by assessing interference from the placebo and by stress testing the drug (forced degradation). The method was linear over the concentration range 20–80 μg/ml (r2 = 0.999) with a Limit of Detection (LOD) and Limit of Quantitation (LOQ) of 0.1 and 0.3 μg/ml respectively. The accuracy of the method was between 99.2–100.5%. The method was found to be robust and suitable for the quantitative analysis of Dronedarone Hydrochloride in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Dronedarone Hydrochloride so the assay is thus stability-indicating.
Highlights
Dronedarone hydrochloride, mainly used for the treatment of cardiac arrhythmias, is chemically N-(2-butyl-3-{4-[3-(dibutylamino)propoxy]benzoyl}-1-benzofuran-5-yl)methanesulfonamide (Fig. 1)
Some articles exist about the analysis of dronedarone in human plasma by liquid chromatographytandem mass spectrometry [2], the combination with amiodarone and their principle metabolites in plasma and myocardium by HStructure of Dronedarone N OHigh-performance Liquid Chromatography (HPLC) and UV-Detection [3], in bulk drugs by HPLC [4], and for the stability-indicating analysis by HPLC [5]
Separation was achieved using a mobile phase consisting of buffer: methanol (40:60 v/v) at a flow rate of 1 ml/min with a short runtime (12 min)
Summary
Dronedarone hydrochloride, mainly used for the treatment of cardiac arrhythmias, is chemically N-(2-butyl-3-{4-[3-(dibutylamino)propoxy]benzoyl}-1-benzofuran-5-yl)methanesulfonamide (Fig. 1). High-performance Liquid Chromatography (HPLC) is a well-known and widely used analytical technique for the analysis of drug products and drug substances. Some articles exist about the analysis of dronedarone in human plasma by liquid chromatographytandem mass spectrometry [2], the combination with amiodarone and their principle metabolites in plasma and myocardium by HPLC and UV-Detection [3], in bulk drugs by HPLC [4], and for the stability-indicating analysis by HPLC [5]. The objective of this work was to develop a stability-indicating liquid chromatographic analytical method for the assay of dronedarone hydrochloride in a tablet formulation. The validation procedure followed the guidelines of the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) [6] and the USP (United States Pharmacopeia) [7]
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