Stability Indicating Fast LC Method for the Estimation of Impurities of Pantoprazole in Tablet Dosage Forms

A fast, stability-indicating reversed phase liquid chromatographic method has been developed and subsequently validated for the estimation of impurities of Pantoprazole. The developed method utilizes sub 2-μm C-18 column and mobile phase consisting of ammonium acetate buffer-acetonitrile with gradient elution, at a flow rate of 0.8 mL per minute. The detection was carried out at 290 nm. The method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification, ruggedness and robustness. This method has been successfully applied to pharmaceutical formulation and no interference from the tablet excipients was found. As the proposed method could effectively separate the drug from its degradants / impurities, ie, pantoprazole related compound A (PA), pantoprazole related compound B (PB), pantoprazole related compound C (PC) and pantoprazole related compound DandF (PDF), it can be employed as stability-indicating method for the determination of instability of the drug in bulk and pharmaceutical formulations.