Development of a New RP-UPLC Method for the Determination of Rabeprazole Sodium in Pharmaceutical Formulation and Application in Dissolution Studies

Abstract

Purpose: To develop a reverse phase ultra-performance liquid chromatographic (RP-UPLC) method for the estimation of rabeprazole sodium in tablet formulations. Methods: Chromatographic separation was achieved on a Waters Acquity BEH C18 (50 x 2.1 mm, particle size 1.7 μm) column using an isocratic method with mobile phase composed of acetonitrile and phosphate buffer (pH 7.4) in the ratio of 35:65 (v/v). The flow rate was 0.4 ml/min, temperature of the column was maintained at ambient, injection volume was 5 μL and detection was made at 280 nm. The run time was as short as 2 min. Comparison of system performance with conventional HPLC was made with respect to analysis time, efficiency and sensitivity. Results: The developed method was linear for rabeprazole sodium from 0.03 - 30 μg/ml and the linear regression obtained was > 0.999. Precision, evaluated by intra- and inter-day assay,s had relative standard deviation (R.S.D) values within 1.5 %. Recovery data were in the range 98.0 - 101.5 % with R.S.D. values < 1.5 %. Conclusion: The method is precise, accurate, linear, robust and fast. The short retention time of 1.49 min allows the analysis of a large number of samples in a short period of time and, therefore, should be cost-effective for routine analysis in the pharmaceutical industry. Keywords: Ultra performance liquid chromatography, Assay, Rabeprazole sodium, Validation