Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method
Abstract
This paper deals with the development of hydrophilic interaction liquid chromatographic (HILIC) method for the analysis of bilastine and its degradation impurities following Analytical Quality by Design approach. It is the first time that the method for bilastine and its impurities is proposed. The main objective was to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Critical process parameters which have the most influence on method performance were defined as acetonitrile content in the mobile phase, pH of the aqueous phase and ammonium acetate concentration in the aqueous phase. Box-Behnken design was applied for establishing a relationship between critical process parameters and critical quality attributes. The defined mathematical models and Monte Carlo simulations were used to identify the design space. Fractional factorial design was applied for experimental robustness testing and the method is validated... to verify the adequacy of selected optimal conditions: the analytical column Luna (R) HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile aqueous phase (50 mM ammonium acetate, pH adjusted to 5.3 with glacial acetic acid) (90.5:9.5, v/v); column temperature 30 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 275 nm.
Source:
Journal of Pharmaceutical and Biomedical Analysis, 2016, 125, 385-393Publisher:
- Elsevier Science BV, Amsterdam
Funding / projects:
- Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-172052)
DOI: 10.1016/j.jpba.2016.04.022
ISSN: 0731-7085
PubMed: 27131148
WoS: 000376474400046
Scopus: 2-s2.0-84964462209
Collections
Institution/Community
PharmacyTY - JOUR AU - Terzić, Jelena AU - Popović, Igor AU - Stajić, Ana AU - Tumpa, Anja AU - Jančić-Stojanović, Biljana PY - 2016 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2548 AB - This paper deals with the development of hydrophilic interaction liquid chromatographic (HILIC) method for the analysis of bilastine and its degradation impurities following Analytical Quality by Design approach. It is the first time that the method for bilastine and its impurities is proposed. The main objective was to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Critical process parameters which have the most influence on method performance were defined as acetonitrile content in the mobile phase, pH of the aqueous phase and ammonium acetate concentration in the aqueous phase. Box-Behnken design was applied for establishing a relationship between critical process parameters and critical quality attributes. The defined mathematical models and Monte Carlo simulations were used to identify the design space. Fractional factorial design was applied for experimental robustness testing and the method is validated to verify the adequacy of selected optimal conditions: the analytical column Luna (R) HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile aqueous phase (50 mM ammonium acetate, pH adjusted to 5.3 with glacial acetic acid) (90.5:9.5, v/v); column temperature 30 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 275 nm. PB - Elsevier Science BV, Amsterdam T2 - Journal of Pharmaceutical and Biomedical Analysis T1 - Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method VL - 125 SP - 385 EP - 393 DO - 10.1016/j.jpba.2016.04.022 ER -
@article{ author = "Terzić, Jelena and Popović, Igor and Stajić, Ana and Tumpa, Anja and Jančić-Stojanović, Biljana", year = "2016", abstract = "This paper deals with the development of hydrophilic interaction liquid chromatographic (HILIC) method for the analysis of bilastine and its degradation impurities following Analytical Quality by Design approach. It is the first time that the method for bilastine and its impurities is proposed. The main objective was to identify the conditions where an adequate separation in minimal analysis duration could be achieved within a robust region. Critical process parameters which have the most influence on method performance were defined as acetonitrile content in the mobile phase, pH of the aqueous phase and ammonium acetate concentration in the aqueous phase. Box-Behnken design was applied for establishing a relationship between critical process parameters and critical quality attributes. The defined mathematical models and Monte Carlo simulations were used to identify the design space. Fractional factorial design was applied for experimental robustness testing and the method is validated to verify the adequacy of selected optimal conditions: the analytical column Luna (R) HILIC (100 mm x 4.6 mm, 5 mu m particle size); mobile phase consisted of acetonitrile aqueous phase (50 mM ammonium acetate, pH adjusted to 5.3 with glacial acetic acid) (90.5:9.5, v/v); column temperature 30 degrees C, mobile phase flow rate 1 mL min(-1), wavelength of detection 275 nm.", publisher = "Elsevier Science BV, Amsterdam", journal = "Journal of Pharmaceutical and Biomedical Analysis", title = "Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method", volume = "125", pages = "385-393", doi = "10.1016/j.jpba.2016.04.022" }
Terzić, J., Popović, I., Stajić, A., Tumpa, A.,& Jančić-Stojanović, B.. (2016). Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. in Journal of Pharmaceutical and Biomedical Analysis Elsevier Science BV, Amsterdam., 125, 385-393. https://doi.org/10.1016/j.jpba.2016.04.022
Terzić J, Popović I, Stajić A, Tumpa A, Jančić-Stojanović B. Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. in Journal of Pharmaceutical and Biomedical Analysis. 2016;125:385-393. doi:10.1016/j.jpba.2016.04.022 .
Terzić, Jelena, Popović, Igor, Stajić, Ana, Tumpa, Anja, Jančić-Stojanović, Biljana, "Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method" in Journal of Pharmaceutical and Biomedical Analysis, 125 (2016):385-393, https://doi.org/10.1016/j.jpba.2016.04.022 . .