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Assay of Daptomycin Injection: Development and Validation of an Environment-friendly CZE Method

[ Vol. 14 , Issue. 4 ]

Author(s):

Ana Paula Christ, Suelen Letícia Burin, Ana Isa Pedroso Marcolino, Cristiane Franco Codevilla, Clarice Madalena Bueno Rolim and Andrea Ines Horn Adams*   Pages 405 - 411 ( 7 )

Abstract:


Background: Daptomycin (DPT) is the first lipopeptide antibiotic available for commercialization, approved by FDA in 2003 and not included in any official compendia.

Introduction: A simple capillary zone electrophoresis method (CZE) to assay DPT injection was developed according to international guidelines.

Methods: The method employed a 15 mmol L-1 pH 8.0 phosphate buffer and acetonitrile (85:15) as background electrolyte, with a voltage of 27 kV, hydrodynamic injection (50 mBar/5 s), and detection at 223 nm. The separation was achieved in a fused silica capillary with 40 cm of effective length, at 22°C, and acetylsalicylic acid was used as internal standard. The specificity was evaluated through a stress test combined with the PDA detector. As a result, the method was specific, even in the presence of degradation products. Detection was assessed around 5.5 min and the method was linear in the range of 20-120 µg mL-1 (r=0.9989).

Results: The results also indicated the precision (RSD values of repeatability and intermediate precision < 2%), and accuracy (mean recovery of 101.26%) of the method. By a full factorial design 23, it was observed that none of the single factors or the combination of them affected the DPT assay, confirming the method robust.

Conclusion: The method proved to be suitable to determine daptomycin injection, in quality control routine assays or in stability studies, and represents an environmentally friendly method.

Keywords:

Capillary zone electrophoresis, daptomycin, daptomycin assay, validation, quality control, factorial design.

Affiliation:

Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal de Santa Maria. Santa Maria, Departamento de Farmacia Industrial, Universidade Federal de Santa Maria. Santa Maria, Programa de Pos-Graduacao em Ciencias Farmaceuticas, Universidade Federal de Santa Maria. Santa Maria, Programa de Pos-Graduacao em Ciencia e Tecnologia de Alimentos, Universidade Federal de Santa Maria, Santa Maria, Departamento de Farmacia Industrial, Universidade Federal de Santa Maria. Santa Maria, Departamento de Farmacia Industrial, Universidade Federal de Santa Maria. Santa Maria

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