title: A Rapid, Validated RP-HPLC Method for the Simultaneous Determination of Cleaning Validation and Cross-Contamination of 12 Beta-Lactam Compounds.
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.
authors: Analytical Research Lab, Cadila Pharmaceutical Ltd, Dholka-387 810, Gujarat, India. ; P. S. Science and H. D. Patel Arts College, S. V. Campus, Kadi-382 715, Gujarat, India.
authors: Harshal Kanubhai
authors: HK
authors: Trivedi
authors: Nayan
authors: N
authors: Kshtri
authors: Mukesh C
authors: MC
authors: Patel
keywords: Cephalosporin; Chromatography; Cleaning validation; Cross contamination; HPLC; Penicillin
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