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

Authorized Users Only
2014
Authors
Đorđević-Filijović, Nataša
Pavlović, Aleksandar
Nikolić, Katarina
Agbaba, Danica
Article (Published version)
Metadata
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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 assessment
Source:
Acta Chromatographica, 2014, 26, 1, 13-28
Publisher:
  • Akademiai Kiado Rt, Budapest
Projects:
  • Synthesis, Quantitative Structure and Activity Relationship, Physico-Chemical Characterisation and Analysis of Pharmacologically Active Substances (RS-172033)

DOI: 10.1556/AChrom.26.2014.1.15

ISSN: 1233-2356

WoS: 000332983800002

Scopus: 2-s2.0-84893581745
[ Google Scholar ]
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/2152
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  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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