Pantoprazole is a proton pump inhibitor (PPI) that inhibits the final stage of gastric acid production by creating a covalent link with two locations of the (H+, K+)-ATPase enzyme system on the secretory surface of the gastric parietal cell. The HPLC method for the determination of related substances in Pantoprazole has been developed and was specific, sensitive, precise, accurate, rapid and robust. The method allows quantification of potential related substances Pantoprazole, impurity A, impurity B, impurity C, impurity D & F &impurity E. Chromatographic separation was achieved on HPLC equipped with UV detector with column. Thermo Hypersil ODS (125 x 4.0) mm, 5µm and the gradient eluted with runtime, 30.0 min. The eluted compounds were monitored at 290 nm, the flow rate was 1.0 mL/min, and the column oven temperature was maintained at 40°C. The resolution between Pantoprazole & Impurity D & F and % RSD of area counts in standard solution was found to be 7.14 and 0.5 respectively, which was under the acceptance criteria. The high correlation coefficient (r2 > 0.999) values indicated clear correlations between the investigated compound concentrations and their peak areas within the test ranges. The developed method was validated according to ICH guidelines. The validation showed that developed method was valid and reliable for determination of pantoprazole and related substances.
Keywords: RP-HPLC, Analytical method development, Calibration curve, Validation
How to cite this article: Singh K, Bhatt S, Dimri T, Bhatt M, Ray R, Kumar N, Analytical method development and validation of pantoprazole and related substances by HPLC. Int J Drug Deliv Technol. 2026;16(2s): 448-464; DOI: 10.25258/ijddt.16.448-464