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 (R) C18 column (5.0 mu m particle size, 250 x 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 degrees 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 reli...able for the purity control in both raw materials and dosage forms.
TY - JOUR
AU - Đorđević-Filijović, Nataša
AU - Pavlović, Aleksandar
AU - Nikolić, Katarina
AU - Agbaba, Danica
PY - 2014
UR - http://farfar.pharmacy.bg.ac.rs/handle/123456789/2152
AB - 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 (R) C18 column (5.0 mu m particle size, 250 x 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 degrees 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.
PB - Akademiai Kiado Rt, Budapest
T2 - Acta Chromatographica
T1 - Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals
VL - 26
IS - 1
SP - 13
EP - 28
DO - 10.1556/AChrom.26.2014.1.15
ER -
@article{
author = "Đorđević-Filijović, Nataša and Pavlović, Aleksandar and Nikolić, Katarina and Agbaba, Danica",
year = "2014",
url = "http://farfar.pharmacy.bg.ac.rs/handle/123456789/2152",
abstract = "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 (R) C18 column (5.0 mu m particle size, 250 x 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 degrees 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.",
publisher = "Akademiai Kiado Rt, Budapest",
journal = "Acta Chromatographica",
title = "Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals",
volume = "26",
number = "1",
pages = "13-28",
doi = "10.1556/AChrom.26.2014.1.15"
}
Đorđević-Filijović, N., Pavlović, A., Nikolić, K.,& Agbaba, D. (2014). Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals.
Acta Chromatographica
Akademiai Kiado Rt, Budapest., 26(1), 13-28.
https://doi.org/10.1556/AChrom.26.2014.1.15
Đorđević-Filijović N, Pavlović A, Nikolić K, Agbaba D. Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals. Acta Chromatographica. 2014;26(1):13-28
Đorđević-Filijović Nataša, Pavlović Aleksandar, Nikolić Katarina, Agbaba Danica, "Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals" Acta Chromatographica, 26, no. 1 (2014):13-28,
https://doi.org/10.1556/AChrom.26.2014.1.15 .
