Development of a novel RP‐HPLC method for the efficient separation of aripiprazole and its nine impurities

Abstract

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 (TC1-TC3) indicated the high prediction potential of the QSRR model for tR 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 (TC1-TC3).

A Compact Analytical Profile of Aripiprazole: Analytical Methodologies

“…As a result, after doing rigorous research and consulting with psychologists, APZ has been recommended to be used to treat bipolar disorder [1]. APZ is a new second generation antipsychotic drug that is used to t schizophrenia as well as acute manic or combined symptoms in people with bipolar 1 disorder [2]. It is also used in the treatment of Tourette's syndrome in children (16 at a dosage of 5-20 mg/day in patients weighing less than 50 kg [3].…”

“…Mixtures of organic solvents with buffers containing acidic or basic additives employed as mobile phases have been widely applied to separate moderately hydrophilic and hydrophobic compounds. The sensitive and reproducible ion pair RPLC method was developed and validated by N. Nikolic K et al[2]…”

Stability indicating liquid chromatographic method for simultaneous quantification of betamethasone valerate and tazarotene in in vitro and ex vivo studies of complex nanoformulation

“…For such combination formulation analysis, there is current need of simultaneous HPLC analysis method which can be utilized to estimate simultaneously betamethasone valerate and tazarotene in the routine analysis of preformulation samples, in vitro drug release samples, ex vivo studies of conventional and complex nanoformulations . Simultaneous method development is advantageous to analyze multiple drugs in a single formulation in a short time which resulted in being cost‐effective for academic and industrial research . According to our literature search, there is no simultaneous HPLC method reported for the estimation of betamethasone valerate and tazarotene in conventional and nanocarriers based topical formulations.…”

Prediction of the retention ofs-triazines in reversed-phase high-performance liquid chromatography under linear gradient-elution conditions

“…This method defines a multivariable response surface y = f ( x 1 , x 2 ,…, x n ) describing the effect of various factors x i on a parameter y of chromatographic interest. The chromatographic resolution of a target mixture is the most common response, while the factors are various instrumental variables, such as mobile phase composition and pH, gradient profile, eluent flux and temperature . Application domains of conventional QSRR and RSM methods can be considered complementary, as the first approach describes the effect of molecular structure on the retention under fixed separation conditions, while the latter method describes the influence of parameters related with the separation mode for a target analyte or mixture.…”