%0 Journal Article
%T Validation and Application of a New Reversed Phase HPLC Method for In Vitro Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets
%A Md. Saddam Nawaz
%J Journal of Analytical Methods in Chemistry
%D 2013
%I Hindawi Publishing Corporation
%R 10.1155/2013/976034
%X The purpose of this study was to develop and validate a new reversed phase high performance liquid chromatographic (RP-HPLC) method to quantify in vitro dissolution assay of rabeprazole sodium in pharmaceutical tablet dosage form. Method development was performed on C 18, £¿mm ID, and 10£¿¦Ìm particle size column, and injection volume was 20£¿¦ÌL using a diode array detector (DAD) to monitor the detection at 280£¿nm. The mobile phase consisted of buffer: acetonitrile at a ratio of 60£¿:£¿40 (v/v), and the flow rate was maintained at 1.0£¿mL/min. The method was validated in terms of suitability, linearity, specificity, accuracy, precision, stability, and sensitivity. Linearity was observed over the range of concentration 0.05¨C12.0£¿¦Ìg/mL, and the correlation coefficient was found excellent >0.999. The method was specific with respect to rabeprazole sodium, and the peak purity was found 99.99%. The method was precise and had relative standard deviations (RSD) less than 2%. Accuracy was found in the range of 99.9 to 101.9%. The method was robust in different variable conditions and reproducible. This proposed fast, reliable, cost-effective method can be used as quality control tool for the estimation of rabeprazole sodium in routine dissolution test analysis. 1. Introduction Since 1980s, proton pump inhibitors (PPIs) are the most potent inhibitors of gastric acid secretion and effective for treating all gastric acid-related disorders, including gastroesophageal reflux disease (GERD), peptic ulcer disease (PUD), and nonsteroidal anti-inflammatory drug- (NSAID-) induced gastropathy. Rabeprazole sodium (RPS) belongs to a class of PPIs that suppresses gastric acid secretion by specific inhibition of the enzyme system of hydrogen/potassium adenosine triphosphatase (H+/K+ ATPase) at the secretory surface of the gastric parietal cell. In contrast to the other PPIs, RPS is the most potent acid secretion inhibitor during first day of dosing [1]. RPS hinders gastric acid secretion up to the final steps [2]. It may also be used with an antibiotic to prevent gastric ulcer caused by infection Helicobacter pylori (H. pylori). Rabeprazole sodium is chemically 2-[{(4)3-methoxypropoxy-3-methyl-2-pyridinyl} sulphinyl] 1-H benzimidazole sodium salt (Figure 1). It has an empirical formula of C18H20N3NaO3S, molecular weight of 381.43, and half-life of 1-2 hour. RPS is a white to yellowish crystalline solid and soluble in water, methanol, and acetonitrile but insoluble in ether and n-hexane. RPS is a substituted benzimidazole which stability is depending on pH. Like most other PPIs, it
%U http://www.hindawi.com/journals/jamc/2013/976034/