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

• Autorzy: Djordjević Filijović N. , Pavlović A. , Nikolić K. , Agbaba D.
• Języki publikacji: EN

Abstrakty

EN

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 KH2PO4 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.

Słowa kluczowe

EN

aripiprazole; impurities; HPLC determination; method validation; purity assessment

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2014
• Tom: Vol. 26, no. 1
• Strony: 13--28
• Opis fizyczny: Bibliogr. 29 poz., rys., tab.

Twórcy

autor

Djordjević Filijović N.

• Hemofarm AD Vrsac Serbia

autor

Pavlović A.

• Hemofarm AD Vrsac Serbia

autor

Nikolić K.

• University of Belgrade, Faculty of Pharmacy Department of Pharmaceutical Chemistry Vojvode Stepe 450 PO Box 146 11000 Belgrade Serbia

autor

Agbaba D.

• University of Belgrade, Faculty of Pharmacy Department of Pharmaceutical Chemistry Vojvode Stepe 450 PO Box 146 11000 Belgrade Serbia

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