Chemometrically Assisted Development and Validation of LC for Simultaneous Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form
Abstract
A chemometrical approach was applied to develop a reversed-phase liquid chromatographic method for simultaneous determination of carbamazepine and its impurities iminostilbene and iminodibenzyl in solid dosage form. According to contemporary literature, no method was developed for simultaneous determination of carbamazepine and these impurities by chemometrical approach. The fractional factorial design was used for selection of variables significantly influencing the chromatographic separation of the investigated substances. The investigated variables were: temperature of the column, the percentage of organic modifier, the acetate buffer concentration and pH of water phase. The first three variables were proved to be significant and were optimized by face centered, central composite design. Investigation was performed using C18 XBridge Shield analytical column (50 mm x 4.6 mm i.d., particle size 3.5 A mu m). The optimal conditions for the separation were established with the mobile pha...se composition of methanol-10 mM acetate buffer (pH adjusted to 2.21 with glacial acetic acid) (50:50, v/v) at a flow rate of 1.5 mL min(-1), 25 A degrees C column temperature and detection at 260 nm. Total analysis time was shortened to about 8 min. Finally, the method was successfully validated and subsequently applied to the analysis of commercially available carbamazepine tablets.
Keywords:
Column liquid chromatography / Fractional factorial design / Central composite design / Carbamazepine / Iminostilbene and iminodibenzylSource:
Chromatographia, 2009, 70, 9-10, 1343-1351Publisher:
- Springer Heidelberg, Heidelberg
Funding / projects:
DOI: 10.1365/s10337-009-1322-6
ISSN: 0009-5893
WoS: 000271540000007
Scopus: 2-s2.0-72949109328
Collections
Institution/Community
PharmacyTY - JOUR AU - Džodić, Predrag AU - Živanović, Ljiljana AU - Protić, Ana AU - Zečević, Mira AU - Jocić, Biljana PY - 2009 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1214 AB - A chemometrical approach was applied to develop a reversed-phase liquid chromatographic method for simultaneous determination of carbamazepine and its impurities iminostilbene and iminodibenzyl in solid dosage form. According to contemporary literature, no method was developed for simultaneous determination of carbamazepine and these impurities by chemometrical approach. The fractional factorial design was used for selection of variables significantly influencing the chromatographic separation of the investigated substances. The investigated variables were: temperature of the column, the percentage of organic modifier, the acetate buffer concentration and pH of water phase. The first three variables were proved to be significant and were optimized by face centered, central composite design. Investigation was performed using C18 XBridge Shield analytical column (50 mm x 4.6 mm i.d., particle size 3.5 A mu m). The optimal conditions for the separation were established with the mobile phase composition of methanol-10 mM acetate buffer (pH adjusted to 2.21 with glacial acetic acid) (50:50, v/v) at a flow rate of 1.5 mL min(-1), 25 A degrees C column temperature and detection at 260 nm. Total analysis time was shortened to about 8 min. Finally, the method was successfully validated and subsequently applied to the analysis of commercially available carbamazepine tablets. PB - Springer Heidelberg, Heidelberg T2 - Chromatographia T1 - Chemometrically Assisted Development and Validation of LC for Simultaneous Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form VL - 70 IS - 9-10 SP - 1343 EP - 1351 DO - 10.1365/s10337-009-1322-6 ER -
@article{ author = "Džodić, Predrag and Živanović, Ljiljana and Protić, Ana and Zečević, Mira and Jocić, Biljana", year = "2009", abstract = "A chemometrical approach was applied to develop a reversed-phase liquid chromatographic method for simultaneous determination of carbamazepine and its impurities iminostilbene and iminodibenzyl in solid dosage form. According to contemporary literature, no method was developed for simultaneous determination of carbamazepine and these impurities by chemometrical approach. The fractional factorial design was used for selection of variables significantly influencing the chromatographic separation of the investigated substances. The investigated variables were: temperature of the column, the percentage of organic modifier, the acetate buffer concentration and pH of water phase. The first three variables were proved to be significant and were optimized by face centered, central composite design. Investigation was performed using C18 XBridge Shield analytical column (50 mm x 4.6 mm i.d., particle size 3.5 A mu m). The optimal conditions for the separation were established with the mobile phase composition of methanol-10 mM acetate buffer (pH adjusted to 2.21 with glacial acetic acid) (50:50, v/v) at a flow rate of 1.5 mL min(-1), 25 A degrees C column temperature and detection at 260 nm. Total analysis time was shortened to about 8 min. Finally, the method was successfully validated and subsequently applied to the analysis of commercially available carbamazepine tablets.", publisher = "Springer Heidelberg, Heidelberg", journal = "Chromatographia", title = "Chemometrically Assisted Development and Validation of LC for Simultaneous Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form", volume = "70", number = "9-10", pages = "1343-1351", doi = "10.1365/s10337-009-1322-6" }
Džodić, P., Živanović, L., Protić, A., Zečević, M.,& Jocić, B.. (2009). Chemometrically Assisted Development and Validation of LC for Simultaneous Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form. in Chromatographia Springer Heidelberg, Heidelberg., 70(9-10), 1343-1351. https://doi.org/10.1365/s10337-009-1322-6
Džodić P, Živanović L, Protić A, Zečević M, Jocić B. Chemometrically Assisted Development and Validation of LC for Simultaneous Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form. in Chromatographia. 2009;70(9-10):1343-1351. doi:10.1365/s10337-009-1322-6 .
Džodić, Predrag, Živanović, Ljiljana, Protić, Ana, Zečević, Mira, Jocić, Biljana, "Chemometrically Assisted Development and Validation of LC for Simultaneous Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form" in Chromatographia, 70, no. 9-10 (2009):1343-1351, https://doi.org/10.1365/s10337-009-1322-6 . .