Development of a New RP-UPLC Method for the Determination of Rabeprazole Sodium in Pharmaceutical Formulation and Application in Dissolution Studies
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
Submission of a manuscript to this journal is a representation that the manuscript has not been published previously and is not under consideration for publication elsewhere.
All authors named in each manuscript would be required to sign a form (to be supplied by the Editor) so that they may retain their copyright in the article but to assign to us (the Publishers) and its licensees in perpetuity, in all forms, formats and media (whether known or created in the future) to (i) publish, reproduce, distribute, display and store the contribution, (ii) translate the contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or abstracts of the contribution, (iii) create any other derivative works(s) based on the contribution, (iv) to exploit all subsidiary rights in the contribution, (v) the inclusion of electronic links from the contribution to third party material where-ever it may be located, and (vi) license any thrid party to do any or all of the above.