Identification of degradation products in stressed tablets of Rabeprazole sodium by HPLC-hyphenated techniques
✍ Scribed by R. Vasu Dev; G. Sai Uday Kiran; B. Venkata Subbaiah; B. Suresh Babu; J. Moses Babu; P. K. Dubey; K. Vyas
- Publisher
- John Wiley and Sons
- Year
- 2009
- Tongue
- English
- Weight
- 189 KB
- Volume
- 47
- Category
- Article
- ISSN
- 0749-1581
- DOI
- 10.1002/mrc.2404
No coin nor oath required. For personal study only.
✦ Synopsis
Abstract
Three unknown impurities of Rabeprazole, a proton pump inhibitor, were formed in the formulated drug under the stress conditions, [40 °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‐(1__H__‐benzo[d]imidazol‐2‐yl)‐3‐methyl‐4‐oxo‐1,4‐dihydropyridine‐2‐carboxylic acid, 1__H__‐benzo [d] imidazole‐2‐sulfonic acid and 4‐(3‐methoxy propoxy)‐3‐methyl‐2‐pyridine carboxylic acid, respectively. Copyright © 2009 John Wiley & Sons, Ltd.