加校正因子的主成分自身对照法测定雷贝拉唑钠中杂质过氧化物砜的含量

Determine of Content of Impurity Rabeprazole Sulfone in Rabeprazole Sodium with Correction Factor and Self Contrast Method

目的:建立加校正因子的主成分自身对照法测定雷贝拉唑钠中杂质过氧化物砜的含量。方法:采用高效液相色谱法,分别精密测定主成分雷贝拉唑钠和杂质过氧化物砜的线性方程,以斜率计算杂质相对于主成分的校正因子,并用该校正因子测定杂质过氧化物砜的含量。通过方法学验证和与外标法的比较证明此方法的可行性。流动相0.05 mol·L-1磷酸盐溶液(用0.05 mol·L-1磷酸二氢钾溶液调节0.05 mol·L-1磷酸氢二钠溶液pH 7.0)-甲醇(40∶60);流速1 mol·min-1;柱温35℃;检测波长290 nm。结果:测得过氧化物砜相对于主成分雷贝拉唑钠的相对保留时间为0.74,校正因子为0.74,经方法学考察验证该方法符合要求,且与外标法无明显差异。结论:用加校正因子的主成分自身对照法测定雷贝拉唑钠中氧化物砜的含量的方法可行。

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.