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Development of a novel RP ‐ HPLC method for the efficient separation of aripiprazole and its nine impurities
Author(s) -
Nikolic Katarina,
Filijović Nataša Djordjević,
Maričić Borislava,
Agbaba Danica
Publication year - 2013
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.201300477
Subject(s) - aripiprazole , chromatography , chemistry , high performance liquid chromatography , impurity , partial least squares regression , mean squared error , analytical chemistry (journal) , mathematics , statistics , psychology , schizophrenia (object oriented programming) , organic chemistry , psychiatry
The development of an RP ‐ HPLC method for the separation of aripiprazole and its nine impurities was performed with the use of partial least squares regression, response surface plot methodology, and chromatographic response function. The HPLC retention times and computed molecular parameters of the aripiprazole and its nine impurities were further used for the quantitative structure–retention relationship ( QSRR ) study. The QSRR model, R 2 : 0.899, Q 2 : 0.832, root mean square error of estimation: 4.761, root mean square error of prediction: 6.614, was developed. Very good agreement between the predicted and observed retention times ( t R ) for three additional aripiprazole impurities ( TC 1– TC 3) indicated the high prediction potential of the QSRR model for t R evaluation of other aripiprazole impurities and metabolites. The developed HPLC method is the first reported method for the efficient separation of aripiprazole and its nine impurities, which could be used for the analysis of an additional three aripiprazole impurities ( TC 1– TC 3).