ABSTRACT
OBJECTIVE: To select appropriate liquid chromatography conditions to determine the correction factors for the related compounds A, B, C, D + F and E of pantoprazole thus to establish the determination method of the related substances. METHODS: The separation was achieved on a C18 column(4. 6 mm × 250 mm, 5 μm) utilizing a mobile phase of acetonitrile and 0.01 mol · mL-1 dipo-tassium hydrogen phosphate(0 min, 80:20; 40 min, 40:60; 45 min, 20:80)at a flow rate of 1.0 mL · min-1. The column temperature was set at 35°C. The compounds were monitored at 288 nm. RESULTS: Pantoprazole sodium and its impurities were well separated by the method. The correction factors of pantoprazole related compounds A, B, C, D + F and E were 0.94, 0.93, 0.67, 0.96 and 0.99. CONCLUSION: The method can be used for the quality control of pantoprazole sodium and its related substances in the preparations.