CAJ | 학술논문

分别用HPLC和LC-MS法分析抗过敏药物盐酸非索非那定两年长期留存样品的杂质变化情况.结果发现3个杂质,主要杂质为α,α-二甲基-4-[4-[4-(羟基二苯甲基)-1-哌啶基]-1-氧代丁基]苯乙酸,两年留样后含量增加了1.53%其余两个杂质为α,α-二甲基-4-[1-羟基-4-[4-(羟基二苯甲基)-1-哌啶基]丁基]苯乙酸甲酯和α,α-二甲基-4-[1-羟基-4-[4-(羟基二苯甲基)-1-哌啶基]丁基]苯乙酸丁酯,含晕基本不变.
분별용HPLC화LC-MS법분석항과민약물염산비색비나정량년장기류존양품적잡질변화정황.결과발현3개잡질,주요잡질위α,α-이갑기-4-[4-[4-(간기이분갑기)-1-고정기]-1-양대정기]분을산,량년류양후함량증가료1.53%기여량개잡질위α,α-이갑기-4-[1-간기-4-[4-(간기이분갑기)-1-고정기]정기]분을산갑지화α,α-이갑기-4-[1-간기-4-[4-(간기이분갑기)-1-고정기]정기]분을산정지,함훈기본불변.
The HPLC and LC-MS methods were used respectively to identify the impurities of anti-allergy agent fexofenadine hydrochlorideafter two years' storage. Three impurities were found and their structures were confirmed; the main impurity is α,α-dimethyl-4- [4- [4- (hydroxydiphenylmethyl) piperidin-l-yl]-l-oxobutyl]benzeneacetic acid, whose content increased 1.53 %. The others are methyl α,α-dimethyl-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]benzeneacetate and butyl α,α-dimethyl-4- [1 -hydroxy-4- [4- (hydroxydiphenylmethyl) piperidin- 1-yl]butyl]benzeneacetate, whose content did not changed significantly during storage.