Abstract:
Simple, accurate, selective and validated stability indicating UV spectrophotometric univariate
and multivariate methods were developed for determination of Aripiprazole in presence of its alkaline and
oxidative degradation products. The developed univariate methods; derivative ratio spectra-zero crossing,
successive derivatives of ratio spectra and mean centering of ratio spectra. The first one used the amplitude of
the first derivative ratio signals at 303.0 nm, the second method depended on the successive derivative of ratio
spectra in two steps and measuring the absorbance of Aripiprazole at 281.0 nm and the third one measured the
mean centered values oat 294.0 nm. Two chemometric multivariate methods were applied; principal component
regression (PCR) and partial least-squares regression (PLS). The selectivity of the proposed methods was
confirmed using laboratory-prepared mixtures. The obtained results were statistically compared with those
obtained with the manufacturer HPLC method, showing no significant difference with in accuracy and precision.
These methods could be applied as stability indicating methods for the determination of Aripiprazole in presence
of its degradation products, in bulk powder or in pharmaceutical formulations.
