Chemometrically assissted optimization and validation of RP-HPLC method for the analysis of itraconazole and its impurities
2013
Autori
Kasagić-Vujanović, IrenaMalenović, Anđelija
Jovanović, Marko
Rakić, Tijana
Jančić-Stojanović, Biljana
Ivanović, Darko
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
This paper presents the chemometrically assisted optimization and validation of the RP-HPLC method intended for the quantitative analysis of itraconazole and its impurities in pharmaceutical dosage forms. To reach the desired chromatographic resolution with a limited number of experiments in a minimum amount of time, Box-Behnken design was used to simultaneously optimize some important chromatographic parameters, such as the acetonitrile content in the mobile phase, pH of the aqueous phase and the column temperature. Separation between itraconazole and impurity F was identified as critical and selected as a response during the optimization. The set optimal mobile phase composition was acetonitrile/water pH 2.5 adjusted with o-phosphoric acid (50:50, V/V). Separations were performed on a Zorbax Eclipse XDB-C18, 4.6 x 150 mm, 5 mu m particle size column with the flow rate 1 mL min(-1), column temperature set at 30 degrees C and UV detection at 256 nm. The established method was then subj...ected to method validation and the required validation parameters were tested. For the robustness evaluation, fractional factorial 2(4-1) design was utilized and factors that might significantly affect the system performance were defined. As other validation parameters were also found to be suitable, the possibility to apply the proposed method for the determination of itraconazole, its impurities B and F in any laboratory under different circumstances has been proven.
Ključne reči:
itraconazole / itraconazole impurities / high performance liquid chromatography / Box-Behnken design / fractional factorial designIzvor:
Acta Pharmaceutica, 2013, 63, 2, 159-173Izdavač:
- Hrvatsko Farmaceutsko Drustov (HFD)-Croation Pharmaceutical Soc, Zagreb
Finansiranje / projekti:
- Modelovanje različitih hromatografskih sistema sa hemometrijskim pristupom u farmaceutskoj analizi (RS-172052)
DOI: 10.2478/acph-2013-0015
ISSN: 1330-0075
PubMed: 23846140
WoS: 000322286100002
Scopus: 2-s2.0-84880796841
Institucija/grupa
PharmacyTY - JOUR AU - Kasagić-Vujanović, Irena AU - Malenović, Anđelija AU - Jovanović, Marko AU - Rakić, Tijana AU - Jančić-Stojanović, Biljana AU - Ivanović, Darko PY - 2013 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1920 AB - This paper presents the chemometrically assisted optimization and validation of the RP-HPLC method intended for the quantitative analysis of itraconazole and its impurities in pharmaceutical dosage forms. To reach the desired chromatographic resolution with a limited number of experiments in a minimum amount of time, Box-Behnken design was used to simultaneously optimize some important chromatographic parameters, such as the acetonitrile content in the mobile phase, pH of the aqueous phase and the column temperature. Separation between itraconazole and impurity F was identified as critical and selected as a response during the optimization. The set optimal mobile phase composition was acetonitrile/water pH 2.5 adjusted with o-phosphoric acid (50:50, V/V). Separations were performed on a Zorbax Eclipse XDB-C18, 4.6 x 150 mm, 5 mu m particle size column with the flow rate 1 mL min(-1), column temperature set at 30 degrees C and UV detection at 256 nm. The established method was then subjected to method validation and the required validation parameters were tested. For the robustness evaluation, fractional factorial 2(4-1) design was utilized and factors that might significantly affect the system performance were defined. As other validation parameters were also found to be suitable, the possibility to apply the proposed method for the determination of itraconazole, its impurities B and F in any laboratory under different circumstances has been proven. PB - Hrvatsko Farmaceutsko Drustov (HFD)-Croation Pharmaceutical Soc, Zagreb T2 - Acta Pharmaceutica T1 - Chemometrically assissted optimization and validation of RP-HPLC method for the analysis of itraconazole and its impurities VL - 63 IS - 2 SP - 159 EP - 173 DO - 10.2478/acph-2013-0015 ER -
@article{ author = "Kasagić-Vujanović, Irena and Malenović, Anđelija and Jovanović, Marko and Rakić, Tijana and Jančić-Stojanović, Biljana and Ivanović, Darko", year = "2013", abstract = "This paper presents the chemometrically assisted optimization and validation of the RP-HPLC method intended for the quantitative analysis of itraconazole and its impurities in pharmaceutical dosage forms. To reach the desired chromatographic resolution with a limited number of experiments in a minimum amount of time, Box-Behnken design was used to simultaneously optimize some important chromatographic parameters, such as the acetonitrile content in the mobile phase, pH of the aqueous phase and the column temperature. Separation between itraconazole and impurity F was identified as critical and selected as a response during the optimization. The set optimal mobile phase composition was acetonitrile/water pH 2.5 adjusted with o-phosphoric acid (50:50, V/V). Separations were performed on a Zorbax Eclipse XDB-C18, 4.6 x 150 mm, 5 mu m particle size column with the flow rate 1 mL min(-1), column temperature set at 30 degrees C and UV detection at 256 nm. The established method was then subjected to method validation and the required validation parameters were tested. For the robustness evaluation, fractional factorial 2(4-1) design was utilized and factors that might significantly affect the system performance were defined. As other validation parameters were also found to be suitable, the possibility to apply the proposed method for the determination of itraconazole, its impurities B and F in any laboratory under different circumstances has been proven.", publisher = "Hrvatsko Farmaceutsko Drustov (HFD)-Croation Pharmaceutical Soc, Zagreb", journal = "Acta Pharmaceutica", title = "Chemometrically assissted optimization and validation of RP-HPLC method for the analysis of itraconazole and its impurities", volume = "63", number = "2", pages = "159-173", doi = "10.2478/acph-2013-0015" }
Kasagić-Vujanović, I., Malenović, A., Jovanović, M., Rakić, T., Jančić-Stojanović, B.,& Ivanović, D.. (2013). Chemometrically assissted optimization and validation of RP-HPLC method for the analysis of itraconazole and its impurities. in Acta Pharmaceutica Hrvatsko Farmaceutsko Drustov (HFD)-Croation Pharmaceutical Soc, Zagreb., 63(2), 159-173. https://doi.org/10.2478/acph-2013-0015
Kasagić-Vujanović I, Malenović A, Jovanović M, Rakić T, Jančić-Stojanović B, Ivanović D. Chemometrically assissted optimization and validation of RP-HPLC method for the analysis of itraconazole and its impurities. in Acta Pharmaceutica. 2013;63(2):159-173. doi:10.2478/acph-2013-0015 .
Kasagić-Vujanović, Irena, Malenović, Anđelija, Jovanović, Marko, Rakić, Tijana, Jančić-Stojanović, Biljana, Ivanović, Darko, "Chemometrically assissted optimization and validation of RP-HPLC method for the analysis of itraconazole and its impurities" in Acta Pharmaceutica, 63, no. 2 (2013):159-173, https://doi.org/10.2478/acph-2013-0015 . .