RP-HPLC gradient elution analysis for the determination of pantoprazole soldium and its related substances / 中国药科大学学报

ABSTRACT

Aim: To establish a method for the determination of pantoprazole sodium and its related substances. Methods: A column packed with octadecylsiance bonded silica gel (250 mm × 4. 6 mm, 5 pjn) was used. The 0. 01 mol/L monopotassium phosphate solution( adjusted with phosphoric acid to pH 7. 0) -acetonitrile were adopted as the mobile phase, a gradient elution was programmed as follows 0→30 min(9010-6040), 30→45 min(60 40→15 85); the detection wavelength was 289 nm; the column temperature was 40 ℃; the flow rate was 1. 0 mL/min. Results: Pantoprazole sodium, the intermediates and its related substances could be well separated. A good linear relationship was obtained over the range of 6. 96-48. 72 μg/mL( r =0. 999 9). The limit detection and quantisation of pantoprazole sodium were 8.51 ng and 17.0 ng, respectively. Conclusion: This method can be applied to control the related substances of pantoprazole sodium and determine pantoprazole sodi-um.