Analytical Method Development and Validation for Related Substances of S (-) Pantoprazole in S (-) Pantoprazole Sodium Tablets 20 MG by HPLC

Abstract

The S- isomer of pantoprazole is known to be more effective and lesser dependent on cytochrome 2C19 than R-isomer of pantoprazole. It is a selective and long-acting proton pump inhibitor. An RP-HPLC method for quantification of S (-) pantoprazole and its three main impurities in pharmaceutical formulations was developed and validated. The separation was accomplished on Inertsil C8-m, 250 mm X mm, 5μ using mobile phase buffer and acetonitrile in proportion 680+320 v/v. The buffer was 0.01 M dibasic sodium hydrogen phosphate anhydrous solution , adjusted to pH 6.0 with orthophosphoric acid. The eluent flow rate was 1.5 mL/min, the column temperature was 25°C, the sample temperature was between 5-8°C, the run time was 50 min, the injection volume was 20 μL and the eluate was monitored at 220 nm. The resolution of S (-) pantoprazole and three impurities was greater than 2 for all pairs of components. The high correlation coefficient (r2 > 0.9999) values indicate excellent correlations between investigated compound concentration and their peak areas within the test ranges. The accuracy evaluated by performing recovery studies via a spike method, was in the range LOQ to 120% with respect to sample concentration for all components. The repeatability and intermediate precision were evaluated and found satisfactory. The 0.45μ nylon syringe filter was found to be suitable after the filter study. The analytical solutions were stable for up to 5 days when stored at 2-8°C and mobile phase for up to 2 days at room temperature. The proposed method can be used for simultaneous identification and quantification of analyzed compounds in pharmaceutical formulations.