摘要
目的建立盐酸普拉克索原料药中有关物质的含量测定方法。方法采用HPLC建立盐酸普拉克索及其杂质A、B、C、E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有关物质的含量。通过方法学考察证明此方法的可行性。结果盐酸普拉克索杂质A、B、C、E的校正因子分别为0.642,0.999,0.796,0.999;相对保留时间为0.703,1.512,1.733,0.522;方法学考察验证该方法符合要求;3批样品中杂质A、B、E均未检出,杂质C的含量分别为0.013%,0.013%,0.012%。结论加校正因子的主成分自身对照法能够准确测定盐酸普拉克索原料药中有关物质的含量。
OBJECTIVE To develop a method for determing the content of related substances of hydrochloric acid pramipexol. METHODS HPLC was used to establish the linear equation of pramipexole hydrochloride and its impurity A, B, C and E. The slope of linear equation was used to determine the correction factor of impurity A, B, C and E, and the validation of the analytical method was determined. RESULTS The correction factors of pramipexole hydrochloride impurity A, B, C and E were 0.642, 0.999, 0.796 and 0.642, and the relative retention time was 0.703, 1.512, 1.733, 1.512. Impurity A, B and E were not detected in 3 batches of samples, and the content of impurity C was respectively 0.013%, 0.013% and 0.012%. CONCLUSIONS The correction factor method is viable to determine the content of related substances of pramipexole hydrochloride dihydrate.
出处
《中国现代应用药学》
CAS
CSCD
2015年第11期1366-1370,共5页
Chinese Journal of Modern Applied Pharmacy
作者简介
李晶，女，硕士生Tel：13512119482E—mail：1007000516@qq．com
通信作者：石森林，男，博士，教授，博导Tel：（0571）86613524E-mail：pjstone@163．com
