Citation: Lakkireddy PRAKASH, M HIMAJA. Stress degradation study and structure characterization of oxidation degradation product of dexlansoprazole using liquid chromatography-mass spectrometry/time of flight, liquid chromatography-tandem mass spectrometry and nuclear magnetic resonance[J]. Chinese Journal of Chromatography, ;2016, 34(3): 279-288. doi: 10.3724/SP.J.1123.2015.08009 shu

Stress degradation study and structure characterization of oxidation degradation product of dexlansoprazole using liquid chromatography-mass spectrometry/time of flight, liquid chromatography-tandem mass spectrometry and nuclear magnetic resonance

Lakkireddy PRAKASH ^1,2,, ,
M HIMAJA ²

1.
1. Department of Analytical Research and Development, Dr. Reddy's Laboratories Ltd, IPDO, Hyderabad 500072, India;
2.
2. Pharmaceutical Chemistry Division, School of Advanced Sciences, VIT University, Vellore 632014, India

Corresponding author: Lakkireddy PRAKASH,
Received Date: 5 August 2015

The present study deals with the forced degradation behavior of dexlansoprazole under International Conference on Harmonisation (ICH) prescribed stress conditions. The drug was found to be more labile under acid, base, neutral, oxidative hydrolysis and thermal stress, while it was moderately stable under photolytic conditions. The known and unknown degradation products were separated on a C-18 column using a stability-indicating method. Liquid chromatography-mass spectrometry (LC-MS) analysis was performed for all the degradation studies. Isolation and structure characterization of oxidation degradation products were executed using sophisticated tools, viz. preparative high performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry/time of flight (LC-MS/TOF), liquid chromatography-tandem mass spectrometry (LC-MS/MS), and nuclear magnetic resonance (NMR). This study demonstrates an ample methodology of degradation studies and structure elucidation of unknown degradation products of dexlansoprazole, which helps in the development and stability study of active pharmaceutical ingredients and formulated products.
- stress degradation,
- isolation,
- spectral characterization,
- dexlansoprazole,
- impurities
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