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Please use this identifier to cite or link to this item: http://acervodigital.unesp.br/handle/11449/111945
Title: 
Development and Validation of A Stability-Indicating Mekc Method for Determination of Flucloxacillin Sodium in Capsules
Author(s): 
Institution: 
  • Universidade Estadual Paulista (UNESP)
  • Universidade Federal do Rio Grande do Sul (UFRGS)
ISSN: 
1573-4110
Sponsorship: 
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
  • PADC (FCF, Araraquara Program, Brazil)
Abstract: 
Flucloxacillin (FLU) is a semi-synthetic penicillin active against Gram-positive bacteria such as streptococci and penicilinase-producing staphylococci, including methicillin-susceptible S. aureus. A simple, rapid and reproducible stability-indicating micellar electrokinetic chromatography (MEKC) method was developed and validated for analysis of flucloxacillin sodium in capsules, using nimesulide as internal standard. The MEKC method was performed on a fused-silica capillary (50 mu m id; effective length of 40 cm). The background electrolyte consists of 50 mM borate and 80 mM anionic surfactant SDS quantities at pH 8.5. The separation was achieved at 20 kV applied voltage and 27.5 degrees C. The injection was performed using the hydrodinamic mode at 50 mbar for 4s, with detection at 210 nm. The method was linear in the range of 20-100 mu g mL(-1) (r = 0.9996) with adequate results for the precision (<= 1.60%) and accuracy (99.45%). The specificity and stability-indicating capability were demonstrated through forced degradation studies and with placebo solution, which showed that there is no interference of the excipients. LOD and LOQ were 3.20 and 9.70 mu g mL(-1), respectively. The method proved to be robust by a fractional factorial design evaluation. The method was successfully applied for the drug analysis and the results were compared to liquid chromatographic method, showing non-significant difference (p > 0.005). The proposed method might be applied in routine quality control in the pharmaceutical industries.
Issue Date: 
1-Jan-2014
Citation: 
Current Analytical Chemistry. Sharjah: Bentham Science Publ Ltd, v. 10, n. 1, p. 149-157, 2014.
Time Duration: 
149-157
Publisher: 
Bentham Science Publ Ltd
Keywords: 
  • Capsules
  • flucloxacillin sodium
  • MEKC method
  • penicillin
  • quality control
  • validation
Source: 
http://dx.doi.org/10.2174/15734110113099990016
URI: 
Access Rights: 
Acesso restrito
Type: 
outro
Source:
http://repositorio.unesp.br/handle/11449/111945
Appears in Collections:Artigos, TCCs, Teses e Dissertações da Unesp

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