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

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

Volume: 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*

Affiliation:

• Departamento de Farmacia Industrial, Universidade Federal de Santa Maria. Santa Maria,Brazil

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

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.

Cite this article as:

Christ Paula Ana , Burin Letícia Suelen , Marcolino Isa Pedroso Ana , Codevilla Franco Cristiane , Rolim Madalena Bueno Clarice and Adams Ines Horn Andrea *, Assay of Daptomycin Injection: Development and Validation of an Environment-friendly CZE Method, Current Pharmaceutical Analysis 2018; 14 (4) . https://dx.doi.org/10.2174/1573412913666170621114323