Identification of degradation products in stressed tablets of Rabeprazole sodium by HPLC-hyphenated techniques.
Three unknown impurities of Rabeprazole, a proton pump inhibitor, were formed in the formulated drug under the stress conditions, [40 degrees C/75% relative humidity (RH) for 6 months] with relative retention times (RRTs) 0.17, 0.22 and 0.28. The Impurity-I (0.17 RRT) was isolated using preparative HPLC and characterized by NMR and MS. The other two impurities, Impurity-II (RRT 0.22) and Impurity-III (RRT 0.28) could not be isolated, hence they are characterized by HPLC-hyphenated techniques, LC-NMR and high-resolution LC-MS. On the basis of the spectral data, the Impurity-I, Impurity-II and Impurity-III were characterized as 1-(1H-benzo[d]imidazol-2-yl)-3-methyl-4-oxo-1,4-dihydropyridine-2-carboxylic acid, 1H-benzo [d] imidazole-2-sulfonic acid and 4-(3-methoxy propoxy)-3-methyl-2-pyridine carboxylic acid, respectively.
Vasu Dev
R
R
Analytical Research, Discovery Research, Dr. Reddy's Laboratories Ltd., Miyapur, Hyderabad 500 049, India. vasudevr@drreddys.com
Sai Uday Kiran
G
G
Venkata Subbaiah
B
B
Suresh Babu
B
B
Moses Babu
J
J
Dubey
P K
PK
Vyas
K
K
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000737:chemistry*; D000897:Anti-Ulcer Agents / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D004355:Drug Stability; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D011312:Pressure; D064750:Rabeprazole; D013607:Tablets
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D013607:Tablets; D064750:Rabeprazole