Development of an UPLC-QTOF-MS Method for the Simultaneous Estimation of Dronedarone and its Unlisted Pharmacopoeial Impurities

Abstract

Abstract: For the first time, an UPLC-QTOF-MS method was developed and validated to simultaneously estimate dronedarone (DDN) and its four unlisted pharmacopoeial impurities: DDN impurities A, B, C, and D. UPLC separation was performed for 6 min on a BEH C18 (50 × 2.1 mm, 1.7 µm) columnwith 0.1% formic acid in water (A) and acetonitrile (B) as mobile phase delivered in gradient at a constant flow rate of 0.6 mL/min. Mass spectrometric detection was performed in ESI-QTOF-MS. The LOD and LOQ values for the analytes ranged from 0.5 to 10 and 0.8 to 75 ng/mL, respectively. The method was found to be linear for all analyte ranges with r 2 values ≥0.9998. The method was precise with %RSD values ≤6.5% and overall analyte recovery was found to be 99.8 ± 1.0%. A novel, sensitive, selective, specific, linear, and accurate UPLC-QTOF-MS method was developed and validated to simultaneously estimate DDN and its impurities which are not listed in the pharmacopoeia.