Identification and characterization of potential impurities of rabeprazole sodium.
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).
Reddy
Ganta Madhusudhan
GM
Research & Development, Integrated Product Development, Active Pharmaceutical Ingredients-III, Dr. Reddy's Laboratories Ltd., Bollaram, Medak 502325, Andhra Pradesh, India.
Bhaskar
B Vijaya
BV
Reddy
P Pratap
PP
Sudhakar
P
P
Babu
J Moses
JM
Vyas
K
K
Reddy
P Ramachandra
PR
Mukkanti
K
K
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000032:analysis* / Q000737:chemistry; D000897:Anti-Ulcer Agents / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D015394:Molecular Structure; D064750:Rabeprazole; D017550:Spectroscopy, Fourier Transform Infrared
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D064750:Rabeprazole