| Identification and characterization of potential impurities of rabeprazole sodium. | |
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MedLine Citation:
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PMID: 17134865 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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). |
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Authors:
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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:
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Type: Journal Article Date: 2006-11-28 |
Journal Detail:
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Title: Journal of pharmaceutical and biomedical analysis Volume: 43 ISSN: 0731-7085 ISO Abbreviation: J Pharm Biomed Anal Publication Date: 2007 Mar |
Date Detail:
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Created Date: 2007-02-26 Completed Date: 2007-04-25 Revised Date: 2013-04-16 |
Medline Journal Info:
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Nlm Unique ID: 8309336 Medline TA: J Pharm Biomed Anal Country: England |
Other Details:
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Languages: eng Pagination: 1262-9 Citation Subset: IM |
Affiliation:
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Research & Development, Integrated Product Development, Active Pharmaceutical Ingredients-III, Dr. Reddy's Laboratories Ltd., Bollaram, Medak 502325, Andhra Pradesh, India. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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2-Pyridinylmethylsulfinylbenzimidazoles
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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:
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0/2-Pyridinylmethylsulfinylbenzimidazoles; 0/Anti-Ulcer Agents; 32828355LL/rabeprazole |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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