Determination of Pantoprazole in Bulk and Pharmaceutical Formulations by Validated Rp-HPLC Method

Abstract

A sensitive, highly specific validated, stability indicating RP-HPLC method for the determination of Pantoprazole in bulk and pharmaceutical dosage forms. The method was developed using Luna CN (250×4.6 mm,5µm) and a mixture of Water: Acetonitrile in the ratio of 30:70 v/v was used as mobile phase at a flow rate of 1.0 mL/min with UV detection at 215 nm for Pantoprazole. The retention time of the drug was 3.7 minutes. The developed method was validated for specificity, linearity, precision, accuracy and robustness as per ICH guidelines. Linearity was found in the range of 10-150 µg/ml. The mean recovery of the drug was 102.0 %. The proposed method could be used for routine analysis of Pantoprazole in their dosage forms and the method is accurate, precise, simple, sensitive and rapid and can be applied successfully for the estimation of Pantoprazole in bulk and in pharmaceutical formulations without interference and with good sensitivity.