Development and validation of zero and first-order derivative area under curve spectrophotometric methods for the determination of aripiprazole in bulk material and tablets

Abstract

The proposed experiments explain simple, precise, specific and accurate UV spectrophotometry methods for the estimation of Aripiprazole in bulk and pharmaceutical formulation. Aripiprazole is a recent second generation atypical anti-psychotic drug used for the treatment of schizophrenia; four simple UV spectrophotometric methods were established for estimation of Aripiprazole, using double beam UV spectrophotometer (UV-2450, Shimadzu, Japan). Aripiprazole showed maximum absorbance (λ max) at 255 nm in methanolic HCl as a solvent. The calibration curve obeyed Beer-Lambert law in the concentration range of 5 -30 μg/mL. The % recovery was found to be in the range of 98 - 100 %. Precision value less than 2 in terms of % RSD indicates precise nature of developed methods. Validation of developed methods was carried out as per ICH guidelines. It was concluded that the results and statistical analysis amongst all four methods, AUC method is most simple, accurate, precise, and specific. All four methods can be used for routine analysis of Aripiprazole in bulk and pharmaceutical formulations. Keywords: Aripiprazole, UV-Spectrophotometry, Derivatives Methods, Area Under Curve Method.