加校正因子的主成分自身对照法测定盐酸普拉克索的有关物质

Determination of Related Substances of Pramipexole Hydrochloride by Correction Factor

关键词:  盐酸普拉克索  高效液相色谱法  有关物质  校正因子

Key words:  hydrochloric acid pramipexole  HPLC  related substances  correction factor

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。

Abstract:

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.