注册 English

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 ,  M HIMAJA

downloadPDF
引用本文: 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. doi: 10.3724/SP.J.1123.2015.08009 shu
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

  • 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

    • 通讯作者: Lakkireddy PRAKASH
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.

English

    1. [1] Dexlansoprazole. (2014-12-17). http://www.drugs.com/cons/dexlansoprazole.html[1] Dexlansoprazole. (2014-12-17). http://www.drugs.com/cons/dexlansoprazole.html

    2. [2] International Conference on Harmonization. ICH Q3A (R2), Impurities in New Drug Substances. 2006: 1[2] International Conference on Harmonization. ICH Q3A (R2), Impurities in New Drug Substances. 2006: 1

    3. [3] International Conference on Harmonization. ICH Q3B (R2), Impurities in New Drug Products, 2006: 1[3] International Conference on Harmonization. ICH Q3B (R2), Impurities in New Drug Products, 2006: 1

    4. [4] U. S. Food and Drug Administration. Drug Stability Guidelines. 1987[4] U. S. Food and Drug Administration. Drug Stability Guidelines. 1987

    5. [5] World Health Organization. WHO Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. Technical Report Series, No. 953, 2009[5] World Health Organization. WHO Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. Technical Report Series, No. 953, 2009

    6. [6] Bartos D, Görög S. Curr Pharm Anal, 2008, 4: 215  [6] Bartos D, Görög S. Curr Pharm Anal, 2008, 4: 215  

    7. [7] Olsen B A, Castle B C, Myers D P. TrAC-Trends Anal Chem, 2006, 25: 796  [7] Olsen B A, Castle B C, Myers D P. TrAC-Trends Anal Chem, 2006, 25: 796  

    8. [8] Ahuja S, Alsante K M. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals. San Diego: Elsevier Science, 2003[8] Ahuja S, Alsante K M. Handbook of Isolation and Characterization of Impurities in Pharmaceuticals. San Diego: Elsevier Science, 2003

    9. [9] Singh S. J Pharm Biomed Anal, 2012, 69: 148  [9] Singh S. J Pharm Biomed Anal, 2012, 69: 148  

    10. [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[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. [11] Hotha K K, Vijaya Bharathi D, Jagadeesh B, et al. Biomed Chromatogr, 2012, 26: 192  [11] Hotha K K, Vijaya Bharathi D, Jagadeesh B, et al. Biomed Chromatogr, 2012, 26: 192  

    12. [12] Cirilli R, Ferretti R, Gallinella B, et al. J Pharmaceut Biomed, 2009, 50(1): 9  [12] Cirilli R, Ferretti R, Gallinella B, et al. J Pharmaceut Biomed, 2009, 50(1): 9  

    13. [13] Battu S, Pottabathini V. Int J Pharm Pharm Sci, 2014, 6(10): 359[13] Battu S, Pottabathini V. Int J Pharm Pharm Sci, 2014, 6(10): 359

    14. [14] Ramulu K, Rao B M, Someswara Rao N. Rasayan J Chem, 2013, 6(4): 274[14] Ramulu K, Rao B M, Someswara Rao N. Rasayan J Chem, 2013, 6(4): 274

    15. [15] Srinivas K S V, Mukkanti K, Buchi Reddy R, et al. E-J Chem, 2010, 7(3): 844  [15] Srinivas K S V, Mukkanti K, Buchi Reddy R, et al. E-J Chem, 2010, 7(3): 844  

    16. [16] Li W, Chen S, Hao L H, et al. Chinese Pharmaceutical Journal, 2010, 45(6): 471[16] Li W, Chen S, Hao L H, et al. Chinese Pharmaceutical Journal, 2010, 45(6): 471

    17. [17] Bhawana N, Abhishek M, Poonam K. Anal Chem Ind J, 2010, 9(1): 137[17] Bhawana N, Abhishek M, Poonam K. Anal Chem Ind J, 2010, 9(1): 137

    18. [18] Reddy G M, Mukkanti K, Kumar T L, et al. Synth Commun, 2008, 38(20): 3477  [18] Reddy G M, Mukkanti K, Kumar T L, et al. Synth Commun, 2008, 38(20): 3477  

    19. [19] Pai N R, Suhas Patil S. J Chem Pharm Res, 2013, 5(7): 121[19] Pai N R, Suhas Patil S. J Chem Pharm Res, 2013, 5(7): 121

    20. [20] Rao P V, Kumar M N, Kumar M R. Sci Pharm, 2013, 81(1): 183  [20] Rao P V, Kumar M N, Kumar M R. Sci Pharm, 2013, 81(1): 183  

    21. [21] Luo Y, Xu L, Xu M, et al. Asian J Pharm Sci, 2012, 7(2): 149[21] Luo Y, Xu L, Xu M, et al. Asian J Pharm Sci, 2012, 7(2): 149

    22. [22] Petkovska R, Cornett C, Dimitrovska A. J Liq Chromatogr Relat Technol, 2008, 31(14): 2159  [22] Petkovska R, Cornett C, Dimitrovska A. J Liq Chromatogr Relat Technol, 2008, 31(14): 2159  

    23. [23] IFPMA. Stability Testing of New Drug Substances and Products Q1A (R2). International Conference on Harmonisation, Geneva, 2003[23] IFPMA. Stability Testing of New Drug Substances and Products Q1A (R2). International Conference on Harmonisation, Geneva, 2003

    24. [24] IFPMA. Photo Stability Testing of New Drug Substances and Products Q1B. International Conference on Harmonisation, Geneva, 1996[24] IFPMA. Photo Stability Testing of New Drug Substances and Products Q1B. International Conference on Harmonisation, Geneva, 1996

    25. [25] Mohan A. J Pharm Biomed Anal, 2008, 47: 183  [25] Mohan A. J Pharm Biomed Anal, 2008, 47: 183  

  • 加载中
WeChat 扫一扫看文章
计量
  • PDF下载量:  0
  • 文章访问数:  622
  • HTML全文浏览量:  58
文章相关
  • 收稿日期:  2015-08-05
通讯作者: 陈斌, bchen63@163.com
  • 1. 

    沈阳化工大学材料科学与工程学院 沈阳 110142

  1. 本站搜索
  2. 百度学术搜索
  3. 万方数据库搜索
  4. CNKI搜索

/

返回文章

All Rights Reserved by the Chinese Chemical Society   中国化学会 版权所有 京ICP备05002797号

本系统由北京仁和汇智信息技术有限公司开发    技术支持: info@rhhz.net