European Journal of Chemistry 2010, 1(1), 20-27 | doi: https://doi.org/10.5155/eurjchem.1.1.20-27.11 | Get rights and content






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Identification of degradation products in Aripiprazole tablets by LC-QToF mass spectrometry


Gosula Venkat Rami Reddy (1) , Avvaru Praveen Kumar (2,*) , Bobba Venkateswara Reddy (3) , Poonam Kumar (4) , Ham Dutt Gauttam (5)

(1) Jubilant Organosys Limited, Noida, Uttarpradesh, India
(2) Department of Chemistry, Yeungnam University, Gyeongsan, 712749, Korea
(3) Jubilant Organosys Limited, Noida, Uttarpradesh, India
(4) Jubilant Organosys Limited, Noida, Uttarpradesh, India
(5) Jubilant Organosys Limited, Noida, Uttarpradesh, India
(*) Corresponding Author

Received: 24 Mar 2010 | Accepted: 24 Mar 2010 | Published: 31 Mar 2010 | Issue Date: March 2010

Abstract


This paper describes the separation, identification and proposed structures of the degradation products formed during degradation analysis of aripiprazole in its final dosage form by high performance liquid chromatography (HPLC) coupled with quadrupole time-of-flight mass spectrometry (QToF-MS). The drug product was subjected to stress conditions including acid, base, thermal, oxidation, humidity and photolytic degradations. Aripiprazole was found to be stable in all conditions except in thermal and peroxide degradations. The degradation impurities were first separated by HPLC and then identified using QToF mass spectrometry. QToF mass spectrometer provided high order of mass accuracy for unknown impurities and their fragment ions to explore the elemental composition. Based on the fragmentation pattern, the possible structures of the unknown impurities were proposed. To the best of our knowledge, there were no methods available to identify the impurities during degradation of aripiprazole tablets by liquid chromatography-mass spectrometry.

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Keywords


Aripiprazole; Identification of degradation impurities; LC-QToF-MS; HPLC

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DOI: 10.5155/eurjchem.1.1.20-27.11

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Funding information


Jubilant Organosys (Noida, India)

Citations

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[1]. Katarina Nikolic, Nataša Djordjević Filijović, Borislava Maričić, Danica Agbaba
Development of a novel RP-HPLC method for the efficient separation of aripiprazole and its nine impurities
Journal of Separation Science  36(19), 3165, 2013
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[2]. Milena Rmandić, Anħelija Malenović
Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles
Journal of Separation Science  , , 2020
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[3]. M. V. V. N. Murali Krishna, Sumathi V. Rao, N. V. S. Venugopal
Identification of degradation impurities in aripiprazole oral solution using LC–MS and development of validated stability indicating method for assay and content of two preservatives by RP-HPLC
Journal of Liquid Chromatography & Related Technologies  40(14), 741, 2017
DOI: 10.1080/10826076.2017.1357572
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[4]. Gudlawar Shivakumar, Jaya Dwivedi
Identification of Degradation Products in Cyclophosphamide API by LC-QTOF Mass Spectrometry
Journal of Liquid Chromatography & Related Technologies  38(2), 190, 2015
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[5]. N. Djordjević Filijović, A. Pavlović, K. Nikolić, D. Agbaba
Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals
Acta Chromatographica  26(1), 13, 2014
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How to cite


Reddy, G.; Kumar, A.; Reddy, B.; Kumar, P.; Gauttam, H. Eur. J. Chem. 2010, 1(1), 20-27. doi:10.5155/eurjchem.1.1.20-27.11
Reddy, G.; Kumar, A.; Reddy, B.; Kumar, P.; Gauttam, H. Identification of degradation products in Aripiprazole tablets by LC-QToF mass spectrometry. Eur. J. Chem. 2010, 1(1), 20-27. doi:10.5155/eurjchem.1.1.20-27.11
Reddy, G., Kumar, A., Reddy, B., Kumar, P., & Gauttam, H. (2010). Identification of degradation products in Aripiprazole tablets by LC-QToF mass spectrometry. European Journal of Chemistry, 1(1), 20-27. doi:10.5155/eurjchem.1.1.20-27.11
Reddy, Gosula, Avvaru Praveen Kumar, Bobba Venkateswara Reddy, Poonam Kumar, & Ham Dutt Gauttam. "Identification of degradation products in Aripiprazole tablets by LC-QToF mass spectrometry." European Journal of Chemistry [Online], 1.1 (2010): 20-27. Web. 13 Jul. 2020
Reddy, Gosula, Kumar, Avvaru, Reddy, Bobba, Kumar, Poonam, AND Gauttam, Ham. "Identification of degradation products in Aripiprazole tablets by LC-QToF mass spectrometry" European Journal of Chemistry [Online], Volume 1 Number 1 (31 March 2010)

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DOI Link: https://doi.org/10.5155/eurjchem.1.1.20-27.11

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