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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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DOI: 10.5155/eurjchem.1.1.20-27.11
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Jubilant Organosys (Noida, India)
Citations
[1]. Krishna Moorthy Manchuri, Mahammad Ali Shaik, Venkata Subba Reddy Gopireddy
A Novel UHPLC–MS/MS Method Development and Validation for Identification and Quantification of Genotoxic Impurity Bis (2-Chloroethyl) Amine in Aripiprazole Drug Substance
Chromatographia 85(2), 137, 2022
DOI: 10.1007/s10337-021-04123-x
[2]. 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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[3]. Bojana Svrkota, Jovana Krmar, Ana Protic, Mira Zecevic, Biljana Otasevic
Optimization of chromatographic separation of aripiprazole and impurities: Quantitative structure-retention relationship approach
Journal of the Serbian Chemical Society 87(5), 615, 2022
DOI: 10.2298/JSC210709092S
[4]. 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 43(16), 3242, 2020
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Journal of Liquid Chromatography & Related Technologies 40(14), 741, 2017
DOI: 10.1080/10826076.2017.1357572
[6]. Frank Alonso Gavilano Fajardo, Marina Franco Maggi Tavares, Anas Rashid, María Segunda Aurora Prado
Novel Eco-Friendly Stability Indicating Capillary Zone Electrophoresis Method for Determination of Aripiprazole in Tablet Dosage form: DoE Directed Optimization, Development and Method Validation
Journal of Pharmaceutical Sciences 111(12), 3340, 2022
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[7]. Gudlawar Shivakumar, Jaya Dwivedi
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Journal of Liquid Chromatography & Related Technologies 38(2), 190, 2015
DOI: 10.1080/10826076.2014.896817
[8]. Jovana Krmar, Ljiljana Tolić Stojadinović, Tatjana Đurkić, Ana Protić, Biljana Otašević
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DOI Link: https://doi.org/10.5155/eurjchem.1.1.20-27.11
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