FarFaR - Pharmacy Repository
University of Belgrade, Faculty of Pharmacy
    • English
    • Српски
    • Српски (Serbia)
  • English 
    • English
    • Serbian (Cyrillic)
    • Serbian (Latin)
  • Login
View Item 
  •   FarFaR
  • Pharmacy
  • Radovi istraživača / Researchers’ publications
  • View Item
  •   FarFaR
  • Pharmacy
  • Radovi istraživača / Researchers’ publications
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

Evaluation of RP-HPLC Method Intended for the Analysis of Cefuroxime Axetil and ITS Impurities Supported by Experimental Design

Authorized Users Only
2013
Authors
Malenović, Anđelija
Vemić, Ana
Kostić, Nada
Ivanović, D.
Article (Published version)
Metadata
Show full item record
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 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.

Keywords:
RP-HPLC / Method validation / Robustness testing / Fractional factorial design / Cefuroxime axetil and its impurities
Source:
Chromatographia, 2013, 76, 5-6, 293-298
Publisher:
  • Springer Heidelberg, Heidelberg
Funding / projects:
  • Modelling of different chromatographic systems with chemometrical approach in pharmaceutical analysis (RS-172052)

DOI: 10.1007/s10337-013-2391-0

ISSN: 0009-5893

WoS: 000315567900009

Scopus: 2-s2.0-84878353072
[ Google Scholar ]
2
1
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1916
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - 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 . .

DSpace software copyright © 2002-2015  DuraSpace
About FarFaR - Pharmacy Repository | Send Feedback

OpenAIRERCUB
 

 

All of DSpaceCommunitiesAuthorsTitlesSubjectsThis institutionAuthorsTitlesSubjects

Statistics

View Usage Statistics

DSpace software copyright © 2002-2015  DuraSpace
About FarFaR - Pharmacy Repository | Send Feedback

OpenAIRERCUB