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2012 | Vol. 24, no. 3 | 367--382
Tytuł artykułu

Stability-indicating RP-HPLC method for analysis of the antibiotic doripenem in pharmaceutical formulation—comparison to UV spectrophotometry and microbiological assay

Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A stability-indicating liquid chromatographic (LC) method with UV detection was developed for the determination of doripenem in the marketed formulation (Doribax® 500 mg, powder for injection). A forced degradation study was conducted according to available guidelines and main references. Thermal, oxidizing, acidic and basic stress conditions were assayed to show the stability-indicating power of the method. Chromatographic separation was achieved using an isocratic elution method in a reversed-phase system using a mobile phase prepared from phosphate buffer and acetonitrile. Extensive degradation was observed under thermal, oxidative and basic treatment, and the products formed were detected without interference in the analysis of doripenem. To verify the efficiency of chromatographic run, the system suitability was studied. The theoretical plates (N = 5498.3) and tailing factor (tf = 0.951) were constant during repeated injections. The retention time of doripenem was 7.35 min and the method was validated within the concentration range 5–50 μg mL-1 (r = 0.999). Adequate results were obtained that indicate repeatability (RSD % = 1.03–1.37), inter-day precision (RSD % = 0.51) and accuracy. In comparison to spectrophotometric and microbiological methods, statistical analysis showed no significant difference between the obtained results. The proposed method was successfully applied to doripenem quantification, showing it is applicable to determine the antibiotic in the presence of degradation products and also that is a reliable method for routine analysis.
Wydawca

Rocznik
Strony
367--382
Opis fizyczny
Bibliogr. 32 poz., rys., tab.
Twórcy
  • Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil
  • Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil
  • Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil
  • Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil
  • Universidade Federal do Rio Grande do Sul Programa de Pós-graduação em Ciências Farmacêuticas Av. Ipiranga 2752 Lab 402 CEP 90610-000 Porto Alegre-RS Brazil
  • Universidade Federal do Rio Grande do Sul Programa de Pós-graduação em Ciências Farmacêuticas Av. Ipiranga 2752 Lab 402 CEP 90610-000 Porto Alegre-RS Brazil
  • Universidade Federal do Pampa Laboratório de Pesquisa e Desenvolvimento em Controle de Qualidade de Medicamentos BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil, andreaslmendez@yahoo.com.br
  • Universidade Federal do Pampa Programa de Pós-graduação em Ciências Farmacêuticas BR 472 km 585 Prédio Administrativo CEP 97500-970 Uruguaiana-RS Brazil
Bibliografia
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  • [18] US Pharmacopoeia XXXI, US Pharmacopeial Convention, Rockville, MD, 2008
  • [19] FDA. Food and Drug Administration, Guidance for Industry—Analytical Procedures and Methods Validation (draft guidance), 2000
  • [20] ICH Q1A (R2). Stability Testing of New Drug Substance and Products: Text and Methodology, In: Proceedings of the International Conference on Harmonization, Geneva, 2003
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Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
bwmeta1.element.baztech-d3469bb5-9235-48a8-bdf6-0b498418e407
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