Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals

Abstract

Summary.Aripiprazole is a novel atypical antipsychotic drug used in the treatment of schizophrenia. The sensitive and reproducible ion pair RPLC method was developed and validated for determination of aripiprazole and its nine impurities, which are significantly different in polarity. The separation was performed on Phenomenex Luna ® C18 column (5.0 μm particle size, 250 × 4.6 mm id) using a gradient mobile phase A (phosphate buffer pH 3.0) and mobile phase B (acetonitrile) at the working temperature of 25°C. The buffer was 1.11 g KH 2 PO 4 with 1.2 g sodium pentanesulfonate/L of the solution, adjusted to pH 3.0 with orthophosphoric acid. The flow rate was 1.0 mL/min. The detection was carried out at 215 nm using a diode array detector. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines for specificity, limit of detection, limit of quantification, linearity, precision and robustness. The proposed method is convenient and reliable for the purity control in both raw materials and dosage forms.

Studying the suitability of hybrid micelle liquid chromatography for estimating the lipophilicity of some partial dopamine agonists used to attain the reward circuit

“…The LOD and LOQ were determined experimentally by calculating the concentrations yielding peaks to noise ratios of 3 : 1 (LOD) or 10 : 1 (LOQ) as stated by the USP [28]. The proposed and reference methods [29][30][31] were applied to determine the concentration of each drug either alone or in laboratory-prepared mixtures. By recognition of the high values of the percentage recoveries, and low values of t and F parameters [32], the accuracy of the proposed method could be easily proved (table 5).…”

“…Accuracy and precision data for the proposed HMLC method. studied drug parameter % found reference methods, % found[29][30][31] application of HMLC for the determination of the drugs in pure form Figures between parentheses are the tabulated t and F values at P = 0.05[32].…”

A novel green HPTLC method for simultaneous analysis of four antipsychotics in their pharmaceutical formulations: Assessment by Eco-scale

“…Aripiprazole (AR),7-(4-[4-(2,3-dichlorophenyl)-1 piperazinyl] (butoxy)-3,4-dihydro-2(1H)-quinolinone is a novel, atypical antipsychotic drug for treatment of schizophrenia (D. Wishart, et al,2018). Several analytical methods were reported to quantify AR in different matrices, include spectrophotometric (Subbayamma, 2010),electrochemical (Merli, 2013), HPLC (Kalaichelvi, 2010);Djordjević Filijović, 2014;Srinivas, 2008 ;Ravinder, 2012;Soponar, 2014) and HPTLC (Patel ,2018;Tawale ,2018).The chosen drugs are from the most frequently prescribed antipsychotics to treat schizophrenia and bipolar disorders (Roberts, 2018;Bjornestad,2020).…”

Chaotropic chromatography method development for the determination of aripiprazole and its impurities following analytical quality by design principles

“…[12] have subjected stress samples to LC–MS in ESI+ mode and identified major degradation products, they have also presented merely determination of aripiprazole in the presence of its degradation products. For the determination of aripiprazole and its nine impurities gradient RP‐HPLC method with acetonitrile, phosphate buffer pH 3.0, and ion‐pairing agent sodium pentanesulfonate in the mobile phase was developed and validated [13]. The RP‐HPLC analysis of complex mixtures with broad range of polarities and acidic–basic characteristics, like aripiprazole and its impurities, is weighted with issues related to chromatographic separation.…”