Der Pharmacia Lettre
Abstract
Author(s): Nandini R. Pai, Deepnandan S. Dubhashi
The present paper describes the development of a simple, rapid and stability indicating reversed
phase column liquid chromatographic method for 7-[4-{4-(2,3-dichlorophenyl) piperazine-1-
yl}butoxy]-3,4-dihydro-1H-quinolin-2-one, a leading antipsychotic drug known by the generic
name Aripiprazole in the presence of its impurities and degradation products generated from
forced decomposition studies. Successful separation of the drug from the synthetic impurities and
degradation products formed under stress conditions is achieved on Zorbax C18 ( 150 x 4.6x 5
micron) using a gradient elution of 0.2% trifluoroacetic acid in water and 0.2% trifluoroacetic
acid in Methanol. The developed LC method is validated as per ICH guideline for validation
parameters like specificity, precision, linearity, accuracy, limit of detection and limit of
quantitation. Linearity of the impurities is established and correlation coefficient is found to be
above 0.995 for every impurities. Recoveries of impurities are found between 100.87% and
103.68%. The proposed validated, stability indicating liquid chromatographic method for the
related substances determination can be used to evaluate quality of Aripiprazole drug samples
from regular production batches. It can also be utilized for testing the stability samples of
Aripiprazole drug which will be of great help to quality control chemist and thus have robust
industrial application.
