Pharma Research Library | Pharma Info Index Research | Innovation | Opportunities |
About author
Vipin Kumar Agrawal *, Alok Singh , Pravesh Kumar, Jyoti Rai, Inamullah
Department of Pharmaceutics, Invertis Institute of Pharmacy,
Invertis University, Bareilly-243 123, Uttar Pradesh, India
Department of Pharmaceutical Chemistry, Invertis Institute of Pharmacy,
Invertis University, Bareilly-243 123, Uttar Pradesh, India
*E-mail: [email protected]
Abstract
Rabeprazole sodium (RSM) is a proton pump inhibitor used against peptic ulcer disease to suppress excess acid secretion in the stomach. A simple, accurate, sensitive and precise Ultraviolet specrophotometric method has been developed for the determination of Rabeprazole sodium in tablet dosage form. The solutions of standard and sample were prepared in 0.1 N Hydrochloric acid. In the UV specrophotometric method, the quantitative determination of the drug was carried at 278 nm and the linearity range was found to be 2-10 μg/ml. The calibration graphs constructed at their wavelength of determination were found to be linear for UV spectrophotometric methods. The proposed methods have been extensively validated statistically that included parameters such as linearity, accuracy, precision, LOD, LOQ, recovery and robustness. There was no significant difference between the performance of the proposed method regarding the mean values and standard deviations. The described methods can be readily utilized for analysis of pharmaceutical formulation.
Key words: Method development, Validation, Rabeprazole sodium
Introduction
Rabeprazole sodium is chemically 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl] methyl]sulfinyl]-1H-Benzimidazole sodium salt. Its molecular formula is C18H20N3NaO3S with molecular weight of 381.43, half-life of 1-2 h and has a oral bioavailability of 52 % when administered orally. Rabeprazole belong to a class of antisecretory compounds that do not exhibit anticholinergic or histamine H2 –receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H+, K+ ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within parietal cell, rabeprazole has been characterized as a gastric proton –pump inhibitor. Rabeprazole blocks the final steps of gastric acid secretion. It is used in the treatment of active duodenal ulcer and active benign gastric ulcer. It is also used in the treatment of gastro–oesophageal reflux disease (GORD). In combination with appropriate antibacterial therapeutic regimens it is being used for the eradication of H. Pylori in patients with peptic ulcer disease. It is official in Indian Pharmacopoeia. Review of literature given in sight that very few spectrocolorimetric and high performance liquid chromatographic method for the analysis of Rabeprazole. Hence present work isto develop a simple and robust UV Spectrophotometric Method and validation for the quantitation of Rabeprazole sodium in bulk fluids and tablets.
