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

ABSTRACT: 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  μ m particle size column, and injection volume was 20  μ 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  μ g/mL, and the correlation coefficient was found excel

SUBMITTER: Nawaz MS 

PROVIDER: S-EPMC3766580 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature