Development and validation of six potential impurities by ultra performance liquid chromatography
electro spray ionization tandem mass (UPLC-ESI-MS/MS) method for dronedarone hydrochloride
drug was accomplished coherent with ICH guidelines. Successful chromatographic separation of
dronedarone with its six impurities was attained by using gradient elution mode on RP-UPLC column
using three pump mode system of 0.1 % formic acid in water as mobile phase A, methanol as the
mobile phase B and solvent mixture of methanol, acetonitrile and water in the ratio of 65:30:5 v/v/v as
the mobile phase C. Chromatographic conditions were set as 0.3 mL min-1 flow rate at the column
temperature of 45 °C with the injection volume 2 μL. Briefly, the method enabled quantitation of six
impurities with high accuracy (recovery > 90 %) and precision (% RSD < 5.0),within the ranges of
0.18-2.82 μg g-1. The regression (r) for each impurity over a range was > 0.99. The detection limit and
quantitation limit of impurities were set at 0.09 and 0.18 μg g-1, respectively. The performed validation
tests proved the suitability of the method for its intended purposes.
Separation of Madecassoside and Madecassic Acid Isomers by High Performance Liquid Chromatography Using β -Cyclodextrin as Mobile Phase Additive