Document Detail


Identification and characterization of potential impurities of rabeprazole sodium.
MedLine Citation:
PMID:  17134865     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Six impurities in rabeprazole sodium bulk drug substance were detected by a simple isocratic high performance chromatographic method (HPLC) whose area percentage ranged from 0.60 to 1.46%. LC-MS was performed to identify the mass of the impurities. A thorough study was undertaken to characterize these impurities. These impurities were synthesized, subsequently characterized and were co-injected with the sample containing impurities and are found to be matching with the impurities in the sample. Based on their spectral data (IR, NMR and MS), these impurities were characterized as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl] methyl]thio]-1H-benzimidazole (impurity I); 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl] methyl] sulfonyl]-1H-benzimidazole (impurity II); 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl-1-oxide] methyl] sulfonyl]-1H-benzimidazole (impurity III); 2-[[[4-(3-methoxypropoxy)-3-methyl] pyridin-2-yl]methanesulfinyl]-1-[[4-(3-methoxypropoxy)-3-methyl]pyridin-2-ylmethyl]-1H-benzimidazole (impurity IV); 2-[[[4-methoxy-3-methyl-2-pyridinyl] methyl] sulfinyl]-1H-benzimidazole (impurity V); 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridine-1-oxide] methyl] sulfinyl]-1H-benzimidazole (impurity VI).
Authors:
Ganta Madhusudhan Reddy; B Vijaya Bhaskar; P Pratap Reddy; P Sudhakar; J Moses Babu; K Vyas; P Ramachandra Reddy; K Mukkanti
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Publication Detail:
Type:  Journal Article     Date:  2006-11-28
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  43     ISSN:  0731-7085     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2007 Mar 
Date Detail:
Created Date:  2007-02-26     Completed Date:  2007-04-25     Revised Date:  2013-04-16    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  1262-9     Citation Subset:  IM    
Affiliation:
Research & Development, Integrated Product Development, Active Pharmaceutical Ingredients-III, Dr. Reddy's Laboratories Ltd., Bollaram, Medak 502325, Andhra Pradesh, India.
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MeSH Terms
Descriptor/Qualifier:
2-Pyridinylmethylsulfinylbenzimidazoles / analysis*,  chemistry
Anti-Ulcer Agents / analysis*,  chemistry
Chromatography, High Pressure Liquid
Drug Contamination
Magnetic Resonance Spectroscopy
Mass Spectrometry
Molecular Structure
Spectroscopy, Fourier Transform Infrared
Chemical
Reg. No./Substance:
0/2-Pyridinylmethylsulfinylbenzimidazoles; 0/Anti-Ulcer Agents; 32828355LL/rabeprazole

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