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

Author(s): Ana Paula Christ, Suelen Letícia Burin, Ana Isa Pedroso Marcolino, Cristiane Franco Codevilla, Clarice Madalena Bueno Rolim, Andrea Ines Horn Adams*.

Journal Name: Current Pharmaceutical Analysis

Volume 14 , Issue 4 , 2018

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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.

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Article Details

VOLUME: 14
ISSUE: 4
Year: 2018
Page: [405 - 411]
Pages: 7
DOI: 10.2174/1573412913666170621114323
Price: $65

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