Evaluation of RP-HPLC Method Intended for the Analysis of Cefuroxime Axetil and ITS Impurities Supported by Experimental Design
Само за регистроване кориснике
2013
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
In this paper, a chemometrically assisted validation of RP-HPLC method, intended for the quantitative analysis of cefuroxime axetil (A and B), cefuroxime acid, cefuroxime lactone, cefuroxime axetil sulfoxide (A and B), a dagger(3)-cefuroxime axetil and anti cefuroxime axetil (A and B) in tablets, is presented. Since the successful separation could be achieved with the mobile phase containing only methanol and water, Luna C18 column was selected for the analysis. Under these circumstances, the optimization was quite straightforward and included only a fine tuning of the chromatographic conditions to reduce total run time and maintain the achieved separation. The established method was then subjected to the method validation and the required validation parameters were tested. For the robustness evaluation, a fractional factorial 2(4-1) design was utilized and factors that might significantly affect the system performance were defined. For the significant factors, the non-significant inte...rvals were determined and the acceptable system suitability limit for resolution factor between cefuroxime axetil A and cefuroxime axetil a dagger(3) isomer (R (2)) was calculated. As the other validation parameters were also found to be suitable, the possibility to apply the proposed method for the determination of cefuroxime axetil, cefuroxime acid, cefuroxime lactone, cefuroxime axetil sulfoxide, a dagger(3)-cefuroxime axetil and anti cefuroxime axetil in any laboratory under different circumstances is proven.
Кључне речи:
RP-HPLC / Method validation / Robustness testing / Fractional factorial design / Cefuroxime axetil and its impuritiesИзвор:
Chromatographia, 2013, 76, 5-6, 293-298Издавач:
- Springer Heidelberg, Heidelberg
Финансирање / пројекти:
- Моделовање различитих хроматографских система са хемометријским приступом у фармацеутској анализи (RS-MESTD-Basic Research (BR or ON)-172052)
DOI: 10.1007/s10337-013-2391-0
ISSN: 0009-5893
WoS: 000315567900009
Scopus: 2-s2.0-84878353072
Институција/група
PharmacyTY - JOUR AU - Malenović, Anđelija AU - Vemić, Ana AU - Kostić, Nada AU - Ivanović, D. PY - 2013 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1916 AB - In this paper, a chemometrically assisted validation of RP-HPLC method, intended for the quantitative analysis of cefuroxime axetil (A and B), cefuroxime acid, cefuroxime lactone, cefuroxime axetil sulfoxide (A and B), a dagger(3)-cefuroxime axetil and anti cefuroxime axetil (A and B) in tablets, is presented. Since the successful separation could be achieved with the mobile phase containing only methanol and water, Luna C18 column was selected for the analysis. Under these circumstances, the optimization was quite straightforward and included only a fine tuning of the chromatographic conditions to reduce total run time and maintain the achieved separation. The established method was then subjected to the method validation and the required validation parameters were tested. For the robustness evaluation, a fractional factorial 2(4-1) design was utilized and factors that might significantly affect the system performance were defined. For the significant factors, the non-significant intervals were determined and the acceptable system suitability limit for resolution factor between cefuroxime axetil A and cefuroxime axetil a dagger(3) isomer (R (2)) was calculated. As the other validation parameters were also found to be suitable, the possibility to apply the proposed method for the determination of cefuroxime axetil, cefuroxime acid, cefuroxime lactone, cefuroxime axetil sulfoxide, a dagger(3)-cefuroxime axetil and anti cefuroxime axetil in any laboratory under different circumstances is proven. PB - Springer Heidelberg, Heidelberg T2 - Chromatographia T1 - Evaluation of RP-HPLC Method Intended for the Analysis of Cefuroxime Axetil and ITS Impurities Supported by Experimental Design VL - 76 IS - 5-6 SP - 293 EP - 298 DO - 10.1007/s10337-013-2391-0 ER -
@article{ author = "Malenović, Anđelija and Vemić, Ana and Kostić, Nada and Ivanović, D.", year = "2013", abstract = "In this paper, a chemometrically assisted validation of RP-HPLC method, intended for the quantitative analysis of cefuroxime axetil (A and B), cefuroxime acid, cefuroxime lactone, cefuroxime axetil sulfoxide (A and B), a dagger(3)-cefuroxime axetil and anti cefuroxime axetil (A and B) in tablets, is presented. Since the successful separation could be achieved with the mobile phase containing only methanol and water, Luna C18 column was selected for the analysis. Under these circumstances, the optimization was quite straightforward and included only a fine tuning of the chromatographic conditions to reduce total run time and maintain the achieved separation. The established method was then subjected to the method validation and the required validation parameters were tested. For the robustness evaluation, a fractional factorial 2(4-1) design was utilized and factors that might significantly affect the system performance were defined. For the significant factors, the non-significant intervals were determined and the acceptable system suitability limit for resolution factor between cefuroxime axetil A and cefuroxime axetil a dagger(3) isomer (R (2)) was calculated. As the other validation parameters were also found to be suitable, the possibility to apply the proposed method for the determination of cefuroxime axetil, cefuroxime acid, cefuroxime lactone, cefuroxime axetil sulfoxide, a dagger(3)-cefuroxime axetil and anti cefuroxime axetil in any laboratory under different circumstances is proven.", publisher = "Springer Heidelberg, Heidelberg", journal = "Chromatographia", title = "Evaluation of RP-HPLC Method Intended for the Analysis of Cefuroxime Axetil and ITS Impurities Supported by Experimental Design", volume = "76", number = "5-6", pages = "293-298", doi = "10.1007/s10337-013-2391-0" }
Malenović, A., Vemić, A., Kostić, N.,& Ivanović, D.. (2013). Evaluation of RP-HPLC Method Intended for the Analysis of Cefuroxime Axetil and ITS Impurities Supported by Experimental Design. in Chromatographia Springer Heidelberg, Heidelberg., 76(5-6), 293-298. https://doi.org/10.1007/s10337-013-2391-0
Malenović A, Vemić A, Kostić N, Ivanović D. Evaluation of RP-HPLC Method Intended for the Analysis of Cefuroxime Axetil and ITS Impurities Supported by Experimental Design. in Chromatographia. 2013;76(5-6):293-298. doi:10.1007/s10337-013-2391-0 .
Malenović, Anđelija, Vemić, Ana, Kostić, Nada, Ivanović, D., "Evaluation of RP-HPLC Method Intended for the Analysis of Cefuroxime Axetil and ITS Impurities Supported by Experimental Design" in Chromatographia, 76, no. 5-6 (2013):293-298, https://doi.org/10.1007/s10337-013-2391-0 . .