SUN Wen-jun1, YAN Hui2, WANG Cheng-gang2. Determine of Content of Impurity Rabeprazole Sulfone in Rabeprazole Sodium with Correction Factor and Self Contrast Method[J]. Chinese journal of experimental traditional medical formulae, 2012, 18(9): 118-122.
SUN Wen-jun1, YAN Hui2, WANG Cheng-gang2. Determine of Content of Impurity Rabeprazole Sulfone in Rabeprazole Sodium with Correction Factor and Self Contrast Method[J]. Chinese journal of experimental traditional medical formulae, 2012, 18(9): 118-122. DOI: 10.13422/j.cnki.syfjx.2012.09.085.
Determine of Content of Impurity Rabeprazole Sulfone in Rabeprazole Sodium with Correction Factor and Self Contrast Method
Objective: The self contrast and correction factor method was established to determinate of rabeprazole sulfone in rabeprazole rodium.Method: The slope of linear equation was used to determine the correction factor between rabeprazole sulfone and rabeprazole sodium.And then
by validation of the analytical method and compare the results determined were compared by the external standard method to ensure the HPLC method to determine the content of impurity rabeprazole sulfone in Rabeprazole sulfone meeting the requirement for the intended analytical applications.Mobile phase:0.05 mol·L-1phosphates solution(0.05 mol·L-1disodium hydrogen phosphate solution is adjusted pH to 7.0 by 0.05 mol·L-1potassium dihydrogen phosphate solution)-methanol(40∶ 60);flow rate: 1 mol·min-1;column temperature 35 ℃;wavelengh 290 nm.Result: The relative retention time between Rabeprazole sulfone and rabeprazole rodium is 0.74 and the correction factor between rabeprazole sulfone and rabeprazole rodium is 0.74
and there is no apparent statistical difference of the contents of rabeprazole sulfone in rabeprazole Sodium determined by the above two methods.Conclusion: The method using the correction factor to determine the content of rabeprazole sulfone in rabeprazole sodium is available.