New liquid chromatographic method for determination of rabeprazole sodium in coated tablets
Garcia, Cássia.V.; Paim, Césio.S.; Steppe, M.
Journal - Association of Official Analytical Chemists 87(4): 842-846
2004
ISSN/ISBN: 0004-5756 PMID: 15295877 Document Number: 580427
Rabeprazole sodium is a proton pump inhibitor that covalently binds and inactivates the gastric parietal cell proton pump (H+/K+ ATPase). Little has been published about the quantitative determination of this drug. The aim of this research was to develop a new liquid chromatographic method for quantitative determination of rabeprazole in coated tablets. The system consisted of a Hypersil Keystone Betabasic C8 column (250 4.6 mm, 5 mm particle size), an isocratic acetonitrile-water (35 + 65) mobile phase at a flow rate of 1.0 mL/min, and a diode array detector set at 282 nm. The following validation parameters were evaluated: linearity, precision, accuracy, specificity, detection and quantitation limits, and robustness. The method showed good linearity in the concentration range of 10-70 mg/mL. The quantitation limit was 2.43 mg/mL, and the detection limit was 0.80 mg/mL. The intra- and interday precision data showed that the method has good reproducibility (relative standard deviation = 1.03). Accuracy and robustness were also evaluated, and the results were satisfactory. The mean recovery was 101.61%. The analysis of a placebo mixture demonstrated the method is also specific. Reprinted by permission of the publisher.