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Vol. 32 No. 5 (2020): Vol 32 Issue 5

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Simultaneous and Trace Level Determination of Six Potential Impurities by UPLC-ESI-MS/MS in Antiarrhythmic Drug: Dronedarone Hydrochloride

K. Durga Raja
Department of Engineering Chemistry, Andhra University, Visakhapatnam-530003, India 2Analytical Research Department, Aurobindo Pharma Limited Research Centre-II, Indrakaran (V), Kandi (M), Sangareddy-502329, India
https://orcid.org/0000-0003-3291-2023
V. Saradhi Venkata Ramana
Department of Engineering Chemistry, Andhra University, Visakhapatnam-530003, India 2Analytical Research Department, Aurobindo Pharma Limited Research Centre-II, Indrakaran (V), Kandi (M), Sangareddy-502329, India
https://orcid.org/0000-0002-9784-858X
K. Raghu Babu
Department of Engineering Chemistry, Andhra University, Visakhapatnam-530003, India
B. Kishore Babu
Department of Engineering Chemistry, Andhra University, Visakhapatnam-530003, India
V. Jagadeesh Kumar
Analytical Research Department, Aurobindo Pharma Limited Research Centre-II, Indrakaran (V), Kandi (M), Sangareddy-502329, India
K.S.R. Pavan Kumar
Analytical Research Department, Aurobindo Pharma Limited Research Centre-II, Indrakaran (V), Kandi (M), Sangareddy-502329, India
Hemant Kumar Sharma
Analytical Research Department, Aurobindo Pharma Limited Research Centre-II, Indrakaran (V), Kandi (M), Sangareddy-502329, India

Corresponding Author(s) : K. Durga Raja

durgaraj.kondempudi@rediffmail.com

Asian Journal of Chemistry, Vol. 32 No. 5 (2020): Vol 32 Issue 5

Abstract

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.

Keywords

Dronedarone hydrochloride Six potential impurities Trace level analysis UPLC-MS/MS Method development Validation
Raja, K. D., Venkata Ramana, V. S., Babu, K. R., Babu, B. K., Kumar, V. J., Pavan Kumar, K., & Sharma, H. K. (2020). Simultaneous and Trace Level Determination of Six Potential Impurities by UPLC-ESI-MS/MS in Antiarrhythmic Drug: Dronedarone Hydrochloride. Asian Journal of Chemistry, 32(5), 1183–1190. Retrieved from https://asianpubs.org/index.php/ajchem/article/view/2499
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