Validated Stability-Indicating HPLC Method for the Determination of Pantoprazole in the Presence of Its Degradation Products

Pantoprazole is a gastric proton pump inhibitor which is used for treatment of gastric and duodenal ulcers. In this report the stress degradation of pantoprazole was studied and an HPLC method was developed for the determination of pantoprazole in the presence of its degradation products. Pantoprazole was relatively stable in basic conditions but unstable under acidic condition, oxidative condition, heat, and light. Separation of pantoprazole and its degradation products was achieved on a Nova-Pak C₁₈ column using a mixture of acetonitrile and KH₂PO₄ 10 mM (pH 7.4) (25:75) as mobile phase. UV detection was performed at 290 nm. The method was linear over the range of 1-50 μg/mL pantoprazole (r²>0.999). The within-day and between-day precision values were also in the range of 0.7-3.1%. The proposed method was successfully used for the determination of pantoprazole in tablets and dissolution medium.