Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals
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 reli...able for the purity control in both raw materials and dosage forms.
Keywords:
aripiprazole / impurities / HPLC determination / method validation / purity assessmentSource:
Acta Chromatographica, 2014, 26, 1, 13-28Publisher:
- Akademiai Kiado Rt, Budapest
Funding / projects:
DOI: 10.1556/AChrom.26.2014.1.15
ISSN: 1233-2356
WoS: 000332983800002
Scopus: 2-s2.0-84893581745
Collections
Institution/Community
PharmacyTY - JOUR AU - Đorđević-Filijović, Nataša AU - Pavlović, Aleksandar AU - Nikolić, Katarina AU - Agbaba, Danica PY - 2014 UR - https://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", 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. in 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. in Acta Chromatographica. 2014;26(1):13-28. doi:10.1556/AChrom.26.2014.1.15 .
Đorđević-Filijović, Nataša, Pavlović, Aleksandar, Nikolić, Katarina, Agbaba, Danica, "Validation of an HPLC method for determination of aripiprazole and its impurities in pharmaceuticals" in Acta Chromatographica, 26, no. 1 (2014):13-28, https://doi.org/10.1556/AChrom.26.2014.1.15 . .