Pharmacokinetics of dronedarone in rat using a newly developed high‐performance liquid chromatographic assay method

Abstract

A sensitive and selective high-performance liquid chromatographic method for the determination of dronedarone in rat plasma was developed. Dronedarone was extracted using one-step liquid-liquid extraction. The separation of dronedarone was accomplished using a C18 analytical column. The mobile phase was composed of a combination of monobasic potassium phosphate and acetonitrile. The UV detection was at 254 nm for ethopropazine, the internal standard, and after its elution, changed to 290 nm for dronedarone detection. The total analytical run time was 20 min. Mean recovery was >80%; the assay had excellent linear relationships (>0.999) between peak height ratios and plasma concentrations; the lower limit of quantification 25 was ng/mL, based on 100 μL of rat plasma. Accuracy and precision were <18% over the concentration range of 25-500 ng/mL. The assay was applied successfully to the measurement of dronedarone plasma concentrations in rats given the drug orally.

Development and validation of an LC‐MS/MS method for the determination of a novel thienoquinolin urea transporter inhibitor PU‐48 in rat plasma and its application to a pharmacokinetic study

“…During method development and optimization of the extraction procedure, several different organic solutions and mixtures were tested, including acetonitrile and ethyl acetate (Jardan, Gabr, & Brocks, ; Kumar et al, ; Wang, Deng, Chen, Guo, & Zhong, ). The result showed that ethyl acetate had higher recovery, lower background and acceptable matrix effects.…”

Development and validation of a high performance liquid chromatography method for determination of 6‐benzyl‐1‐benzyloxymethyl‐5‐iodouracil (W‐1), a novel non‐nucleoside reverse transcriptase inhibitor and its application to a pharmacokinetic study in rats

“…It was found that a mixture of acetonitrile and distilled water (60:40, v/v) was the optimized mobile phase with better resolution, lower background noise, more symmetrical peaks and short retention time for analytes. During method development and optimization of the extraction procedure, several different organic solutions and mixtures were tested, including acetonitrile and ethyl acetate ( Jardan et al, 2014;Kumar et al, 2013). The result showed that ethyl acetate had higher recovery with lower background.…”

The pharmacokinetics of dronedarone in normolipidemic and hyperlipidemic rats

“…Dronedarone HCl tablets (Multaq) was from Sanofi‐Aventis (Laval, PQ, Canada). Chemicals and sources used for drug analysis were as reported previously . Isoflurane USP was purchased from Halocarbon Products Corporation (River Edge, NJ, USA).…”

“…The measurements of dronedarone was accomplished using HPLC. The validated lower limit of quantitation was 25 ng/mL for dronedarone, based on 0.1 mL of plasma .…”