Identification and characterization of potential impurities of rabeprazole sodium |
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Authors: | Reddy Ganta Madhusudhan Bhaskar B Vijaya Reddy P Pratap Sudhakar P Babu J Moses Vyas K Reddy P Ramachandra Mukkanti K |
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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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Abstract: | 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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Keywords: | Rabeprazole sodium Impurities Spectroscopy Identification and characterisation |
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