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

doi:10.3724/SP.J.1123.2015.08009

色谱 ›› 2016, Vol. 34 ›› Issue (3): 279-288.DOI: 10.3724/SP.J.1123.2015.08009

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 HIMAJA²

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

收稿日期:2015-08-05 出版日期:2016-03-08 发布日期:2012-09-28
通讯作者: Lakkireddy PRAKASH

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 HIMAJA²

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

Received:2015-08-05 Online:2016-03-08 Published:2012-09-28
Contact: Lakkireddy PRAKASH

摘要/Abstract

摘要：

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.

关键词: dexlansoprazole, impurities, isolation, spectral characterization, stress degradation

Abstract:

Key words: dexlansoprazole, impurities, isolation, spectral characterization, stress degradation

中图分类号:

O658

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]. 色谱, 2016, 34(3): 279-288.

参考文献

[1] Dexlansoprazole. (2014-12-17). http://www.drugs.com/cons/dexlansoprazole.html
[2] International Conference on Harmonization. ICH Q3A (R2), Impurities in New Drug Substances. 2006: 1
[3] International Conference on Harmonization. ICH Q3B (R2), Impurities in New Drug Products, 2006: 1
[4] U. S. Food and Drug Administration. Drug Stability Guidelines. 1987
[5] World Health Organization. WHO Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. Technical Report Series, No. 953, 2009
[6] Bartos D, Görög S. Curr Pharm Anal, 2008, 4: 215
[7] Olsen B A, Castle B C, Myers D P. TrAC-Trends Anal Chem, 2006, 25: 796
[8] Ahuja S, Alsante K M. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals. San Diego: Elsevier Science, 2003
[9] Singh S. J Pharm Biomed Anal, 2012, 69: 148
[10] U. S. Food and Drug Administration. FDA Approves Name Change for Heartburn Drug Kapidex. [2015-08-05]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm203096.htm
[11] Hotha K K, Vijaya Bharathi D, Jagadeesh B, et al. Biomed Chromatogr, 2012, 26: 192
[12] Cirilli R, Ferretti R, Gallinella B, et al. J Pharmaceut Biomed, 2009, 50(1): 9
[13] Battu S, Pottabathini V. Int J Pharm Pharm Sci, 2014, 6(10): 359
[14] Ramulu K, Rao B M, Someswara Rao N. Rasayan J Chem, 2013, 6(4): 274
[15] Srinivas K S V, Mukkanti K, Buchi Reddy R, et al. E-J Chem, 2010, 7(3): 844
[16] Li W, Chen S, Hao L H, et al. Chinese Pharmaceutical Journal, 2010, 45(6): 471
[17] Bhawana N, Abhishek M, Poonam K. Anal Chem Ind J, 2010, 9(1): 137
[18] Reddy G M, Mukkanti K, Kumar T L, et al. Synth Commun, 2008, 38(20): 3477
[19] Pai N R, Suhas Patil S. J Chem Pharm Res, 2013, 5(7): 121
[20] Rao P V, Kumar M N, Kumar M R. Sci Pharm, 2013, 81(1): 183
[21] Luo Y, Xu L, Xu M, et al. Asian J Pharm Sci, 2012, 7(2): 149
[22] Petkovska R, Cornett C, Dimitrovska A. J Liq Chromatogr Relat Technol, 2008, 31(14): 2159
[23] IFPMA. Stability Testing of New Drug Substances and Products Q1A (R2). International Conference on Harmonisation, Geneva, 2003
[24] IFPMA. Photo Stability Testing of New Drug Substances and Products Q1B. International Conference on Harmonisation, Geneva, 1996
[25] Mohan A. J Pharm Biomed Anal, 2008, 47: 183

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

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

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