Validation and Application of a New Reversed Phase HPLC Method for<i>In Vitro</i>Dissolution Studies of Rabeprazole Sodium in Delayed-Release Tablets

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<jats:p>The purpose of this study was to develop and validate a new reversed phase high performance liquid chromatographic (RP-HPLC) method to quantify<jats:italic>in vitro</jats:italic>dissolution assay of rabeprazole sodium in pharmaceutical tablet dosage form. Method development was performed on C 18,<mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M1"><mml:mn>100</mml:mn><mml:mo>×</mml:mo><mml:mn>4.6</mml:mn></mml:math> mm ID, and 10 <jats:italic>μ</jats:italic>m particle size column, and injection volume was 20 <jats:italic>μ</jats:italic>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 <jats:italic>μ</jats:italic>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.</jats:p>

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