Validation and application of a new reversed phase HPLC method for in vitro dissolution studies of rabeprazole sodium in delayed-release tablets

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 18,100 × 4.6 mm id,and 10 m particle size column,and injection volume was 20 l 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 0.05-12.0 g/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. © 2013 md. saddam nawaz.