Method Development and Validation for the Simultaneous Estimation of Esomeprazole and Levosulpiride by using RPHPLC in its bulk and pharmaceutical dosage form
Esomeprazole is a compound that inhibits gastric acid secretion and is indicated in the treatment of gastroesophageal reflux disease (GERD), the healing of
erosive esophagitis, and H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Esomeprazole belongs to a new class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or H2 histamine antagonistic properties, but that suppress gastric acid secretion by specific inhibition of the H+/K+ATPase at the secretory surface of the gastric parietal cell. By doing so, it inhibits acid secretion into the gsatric lumen. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.
A simple, Accurate, precise method was developed for the simultaneous estimation of the esomeprazole and levosulpiride in Tablet dosage form.
Chromatogram was run through ODS (150mm 4.6mm, 5μ). Mobile phase containing Buffer and Acetonitrie in the ratio of 32;68A was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 0.01N KH2PO4 pH 5.4 buffer.
Temperature was maintained at 30°C. Optimized wavelength for Esomeprazole and Levosulpiride was 290nm. Retention time of Esomeprazole and Levosulpiride were found to be 2.2min and 4.0min. %RSD of the Esomeprazole and Levosulpiride were
and found to be 0.97 and 0.50 respectively. %Recover was Obtained as 100.08% and 101.16% for Esomeprazole and Levosulpiride respectively. LOD, LOQ values are
obtained from regression equations of Esomeprazole and Levosulpiride were 0.10ppm, 0.34ppm and 1.04ppm, 0.29ppm respectively. Regression equation of Esomeprazole is y = 10568.x + 307.3, and of Levosulpiride is y = 11649.x + 1207
