Open AccessSimultaneous and Trace Level Determination of Six Potential Impurities by UPLC-ESI-MS/MS in Antiarrhythmic Drug: Dronedarone Hydrochloride
Author(s) -
K. Durga Raja,
V. Saradhi Venkata Ramana,
K. Raghu Babu,
B. Babu,
Vundavilli Jagadeesh Kumar,
Karunesh Kumar,
Hemant Sharma
Publication year - 2020
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2020.22588
Subject(s) - chemistry , chromatography , impurity , formic acid , dronedarone , high performance liquid chromatography , methanol , detection limit , analytical chemistry (journal) , atrial fibrillation , medicine , amiodarone , organic chemistry , cardiology
Development and validation of six potential impurities by ultra performance liquid chromatographyelectro spray ionization tandem mass (UPLC-ESI-MS/MS) method for dronedarone hydrochloridedrug was accomplished coherent with ICH guidelines. Successful chromatographic separation ofdronedarone with its six impurities was attained by using gradient elution mode on RP-UPLC columnusing three pump mode system of 0.1 % formic acid in water as mobile phase A, methanol as themobile phase B and solvent mixture of methanol, acetonitrile and water in the ratio of 65:30:5 v/v/v asthe mobile phase C. Chromatographic conditions were set as 0.3 mL min-1 flow rate at the columntemperature of 45 °C with the injection volume 2 μL. Briefly, the method enabled quantitation of siximpurities with high accuracy (recovery > 90 %) and precision (% RSD < 5.0),within the ranges of0.18-2.82 μg g-1. The regression (r) for each impurity over a range was > 0.99. The detection limit andquantitation limit of impurities were set at 0.09 and 0.18 μg g-1, respectively. The performed validationtests proved the suitability of the method for its intended purposes.