Abstract
The present work reports a rapid reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of 12 beta-lactam components for cleaning validation and cross-contamination. A strategic experimental approach was implemented for the method development. The desired chromatographic separation was achieved on a Symmetry C18 (4.6 X 75 mm, 3.5 μm) column using gradient elution. The optimized mobile phase consisted of the buffer tetrabutylammonium hydroxide pH-6.8 and acetonitrile. The eluted compounds were monitored at 215 nm and 254 nm wavelength using a photodiode array detector. The developed method separated 12-beta-lactam compounds from each other within a run time of 50 min. The method is effective for the determination of cross-contamination of penicillin and cephalosporin production blocks. The present method is specific and a lower limit of quantification was determined on the basis of the signal-to-noise ratio method; it is 1 μg/mL for all components. The developed RP-HPLC method was validated according to the International Conference on Harmonization (ICH) guidelines.
Highlights
12 Beta-Lactam CompoundsPublished: Accepted: November 17th 2012 November 17th 2012 doi:10.3797/scipharm.1208-20
The high allergic potential of drugs belonging to the penicillin family known as ß-lactam antibiotics makes the production and packaging of such products a focus of crosscontamination control in the pharmaceutical industry
The Unites States Food and Drug Administration (US FDA) guidelines for the manufacture of penicillin and cephalosporin antibiotics require such manufacture to be undertaken in dedicated facilities or on a campaign basis in a multiproduct facility
Summary
Published: Accepted: November 17th 2012 November 17th 2012 doi:10.3797/scipharm.1208-20. © Trivedi et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m.
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