Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form by Column High-Performance Liquid Chromatography
Само за регистроване кориснике
2010
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
An accurate and precise RP-HPLC method was developed and validated for the determination of carbamazepine and its impurities iminostilbene and iminodibenzyl in a tablet formulation with fluphenazine as an internal standard. Buffer methanol (50 + 50, v/v) was used as the mobile phase. During validation, specificity, linearity, precision, accuracy, LOD, LOQ, and robustness of the method were tested. The method was proven to be specific against placebo interference. Linearity was evaluated over the concentration range of 100-500, 0.05-0.25, and 0.1-0.5 mu g/mL, and the r values were 0.9994, 0.9997, and 0.9979 for carbamazepine, iminostilbene, and iminodibenzyl, respectively. Intraday precision of the method was good, and RSD was below 2% for all analytes. The accuracy of the method ranged from 100.69 to 102.10, 99.76 to 102.66, and 99.26 to 100.08% for carbamazepine, iminostilbene, and iminodibenzyl, respectively. LOD was 0.0125, 0.025, and 0.05 mu g/mL and LOQ was 0.05, 0.05, and 0.1 mu ...g/mL for carbamazepine, iminostilbene, and iminodibenzyl, respectively. Robustness of the method was proven by using a chemometric approach. The method was successfully applied to the analysis of commercially available carbamazepine tablets and showed good repeatability, with RSD below 2%.
Извор:
Journal of AOAC International, 2010, 93, 4, 1059-1068Издавач:
- AOAC Int, Gaithersburg
Финансирање / пројекти:
- Синтеза, квантитативни односи између структуре/особина и активности, физичко-хемијска карактеризација и анализа фармаколошки активних супстанци (RS-MESTD-MPN2006-2010-142071)
DOI: 10.1093/jaoac/93.4.1059
ISSN: 1060-3271
PubMed: 20922935
WoS: 000281492100002
Scopus: 2-s2.0-77956151259
Институција/група
PharmacyTY - JOUR AU - Džodić, Predrag AU - Živanović, Ljiljana AU - Protić, Ana AU - Zečević, Mira AU - Jocić, Biljana PY - 2010 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1341 AB - An accurate and precise RP-HPLC method was developed and validated for the determination of carbamazepine and its impurities iminostilbene and iminodibenzyl in a tablet formulation with fluphenazine as an internal standard. Buffer methanol (50 + 50, v/v) was used as the mobile phase. During validation, specificity, linearity, precision, accuracy, LOD, LOQ, and robustness of the method were tested. The method was proven to be specific against placebo interference. Linearity was evaluated over the concentration range of 100-500, 0.05-0.25, and 0.1-0.5 mu g/mL, and the r values were 0.9994, 0.9997, and 0.9979 for carbamazepine, iminostilbene, and iminodibenzyl, respectively. Intraday precision of the method was good, and RSD was below 2% for all analytes. The accuracy of the method ranged from 100.69 to 102.10, 99.76 to 102.66, and 99.26 to 100.08% for carbamazepine, iminostilbene, and iminodibenzyl, respectively. LOD was 0.0125, 0.025, and 0.05 mu g/mL and LOQ was 0.05, 0.05, and 0.1 mu g/mL for carbamazepine, iminostilbene, and iminodibenzyl, respectively. Robustness of the method was proven by using a chemometric approach. The method was successfully applied to the analysis of commercially available carbamazepine tablets and showed good repeatability, with RSD below 2%. PB - AOAC Int, Gaithersburg T2 - Journal of AOAC International T1 - Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form by Column High-Performance Liquid Chromatography VL - 93 IS - 4 SP - 1059 EP - 1068 DO - 10.1093/jaoac/93.4.1059 UR - https://hdl.handle.net/21.15107/rcub_farfar_1341 ER -
@article{ author = "Džodić, Predrag and Živanović, Ljiljana and Protić, Ana and Zečević, Mira and Jocić, Biljana", year = "2010", abstract = "An accurate and precise RP-HPLC method was developed and validated for the determination of carbamazepine and its impurities iminostilbene and iminodibenzyl in a tablet formulation with fluphenazine as an internal standard. Buffer methanol (50 + 50, v/v) was used as the mobile phase. During validation, specificity, linearity, precision, accuracy, LOD, LOQ, and robustness of the method were tested. The method was proven to be specific against placebo interference. Linearity was evaluated over the concentration range of 100-500, 0.05-0.25, and 0.1-0.5 mu g/mL, and the r values were 0.9994, 0.9997, and 0.9979 for carbamazepine, iminostilbene, and iminodibenzyl, respectively. Intraday precision of the method was good, and RSD was below 2% for all analytes. The accuracy of the method ranged from 100.69 to 102.10, 99.76 to 102.66, and 99.26 to 100.08% for carbamazepine, iminostilbene, and iminodibenzyl, respectively. LOD was 0.0125, 0.025, and 0.05 mu g/mL and LOQ was 0.05, 0.05, and 0.1 mu g/mL for carbamazepine, iminostilbene, and iminodibenzyl, respectively. Robustness of the method was proven by using a chemometric approach. The method was successfully applied to the analysis of commercially available carbamazepine tablets and showed good repeatability, with RSD below 2%.", publisher = "AOAC Int, Gaithersburg", journal = "Journal of AOAC International", title = "Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form by Column High-Performance Liquid Chromatography", volume = "93", number = "4", pages = "1059-1068", doi = "10.1093/jaoac/93.4.1059", url = "https://hdl.handle.net/21.15107/rcub_farfar_1341" }
Džodić, P., Živanović, L., Protić, A., Zečević, M.,& Jocić, B.. (2010). Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form by Column High-Performance Liquid Chromatography. in Journal of AOAC International AOAC Int, Gaithersburg., 93(4), 1059-1068. https://doi.org/10.1093/jaoac/93.4.1059 https://hdl.handle.net/21.15107/rcub_farfar_1341
Džodić P, Živanović L, Protić A, Zečević M, Jocić B. Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form by Column High-Performance Liquid Chromatography. in Journal of AOAC International. 2010;93(4):1059-1068. doi:10.1093/jaoac/93.4.1059 https://hdl.handle.net/21.15107/rcub_farfar_1341 .
Džodić, Predrag, Živanović, Ljiljana, Protić, Ana, Zečević, Mira, Jocić, Biljana, "Determination of Carbamazepine and Its Impurities Iminostilbene and Iminodibenzyl in Solid Dosage Form by Column High-Performance Liquid Chromatography" in Journal of AOAC International, 93, no. 4 (2010):1059-1068, https://doi.org/10.1093/jaoac/93.4.1059 ., https://hdl.handle.net/21.15107/rcub_farfar_1341 .