Key result
Cerium ammonium sulfate spectrophotometry successfully quantifies dronedarone in formulations.
Sensitive, simple, and accurate spectrophotometric methods were successfully developed and validated for the assay of dronedarone hydrochloride in bulk and tablet forms.
May aid dronedarone formulation assay; leaves open adoption in regulatory or clinical labs pending further validation.
• A spectrophotometric method has been devised to quantify the arrhythmias medication, dronedarone hydrochloride in dose forms. • The approach utilizes cerium(IV) ammonium sulfate as an oxidizing agent and three dyes. • The concentration ranges for amaranth, methylene blue, and indigo carmine are 1.0–10 µg mL -1 , 1.0–15 µg mL -1 , and 1.0–8.0 µg mL -1 , respectively. • The accuracy and precision of the methods have been evaluated for measurements taken within a single day as well as those taken across multiple days. Sensitive, simple, and accurate spectrophotometric methods have been developed for the assay of arrhythmias drug-dronedarone hydrochloride (DND) in bulk drug and pharmaceutical formulations. The proposed method is based on the oxidation reaction of DND with a known excess of cerium(IV) ammonium sulfate (Ce(IV)) as an oxidizing agent in acid medium, followed by the determination of the unreacted oxidant by adding a fixed amount of dye, e.g., amaranth (AM), methylene blue (MB), and indigocarmine (IC), followed by measuring the absorbance at 520, 664, and 610 nm, respectively. The effects of experimental conditions were studied and optimized. The beer's law was obeyed in the concentration ranges of 1.0–10, 1.0–15, and 1.0–8.0 μg mL -1 using AM, MB, and IC dyes, respectively, with a correlation coefficient ≥ 0.9992. The calculated molar absorptivity values are 3.6527 × 10 4 , 3.1212 × 10 4 , and 4.229 × 10 4 L mol -1 cm -1 using AM, MB, and IC dyes, respectively. The limits of detection and quantification were 0.30 and 1.0 µg mL -1 , respectively, for the three methods. Intra-day and inter-day accuracy and precision of the methods have been evaluated. No interference was observed from the additives. The proposed methods were successfully applied to the assay of DND in tablet preparations and the results were statistically compared with those of the reported method by applying Student's t -test and F-test. The reliability of the methods was further ascertained by performing recovery studies using the standard addition method.
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Sheikh et al. (2024) studied Arrhythmias (drug analysis). Spectrophotometric methods vs. Reported method was evaluated on Assay of dronedarone hydrochloride. Spectrophotometric methods using cerium(IV) ammonium sulfate and dyes were successfully developed and validated for quantifying dronedarone hydrochloride in bulk and pharmaceutical formulations.