Abstract
An isocratic high-performance liquid chromatographic method has been developed for assay of ceftiofur sodium in drug substance and in sterile powder for injection. Chromatography was performed on a 250 mm × 4.6 mm, 5 μm particle, C18 column with a 78:22 (v/v) mixture of 0.02 m disodium hydrogen phosphate buffer (pH adjusted to 6.0 with 85% orthophosphoric acid) and acetonitrile as mobile phase, at a flow rate of 1.0 mL min−1. The separation was monitored by UV detection at 292 nm. Validation of the method for linearity and range, intra- and inter-day precision, accuracy, specificity, recovery, robustness, and limits of quantification and detection yielded good results. The calibration plot was linear from 20.0–120.0 μg mL−1 and the correlation coefficient was 0.9999. It was shown that ceftiofur was degraded under acidic, alkaline, oxidative, and photolytic conditions. The method was found to be stability-indicating and could be used for routine analysis of ceftiofur sodium for injection.
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Acknowledgements
The authors wish to thank Eurofarma Laboratories Ltda, São Paulo, Brazil, for providing the reference substance. This study was performed with the collaboration of Universidade Federal do Rio Grande do Sul-UFRGS and Universidade Federal de Santa Maria-UFSM.
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Souza, M.J.e., Nogueira, D.R., Silva, L.M. et al. Development and Validation of an HPLC Method for Determination of Ceftiofur Sodium. Chroma 65, 401–406 (2007). https://doi.org/10.1365/s10337-006-0163-9
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DOI: https://doi.org/10.1365/s10337-006-0163-9