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Sci. Pharm. 2013, 81(1), 151-166; doi:10.3797/scipharm.1208-20

A Rapid, Validated RP-HPLC Method for the Simultaneous Determination of Cleaning Validation and Cross-Contamination of 12 Beta-Lactam Compounds

1
Analytical Research Lab, Cadila Pharmaceutical Ltd, Dholka-387 810, Gujarat, India
2
P. S. Science and H. D. Patel Arts College, S. V. Campus, Kadi-382 715, Gujarat, India
*
Author to whom correspondence should be addressed.
Received: 30 August 2012 / Accepted: 17 November 2012 / Published: 17 November 2012
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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 cephalo-sporin 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.
Keywords: Chromatography; Cleaning validation; Cross contamination; Penicillin; Cephalosporin; HPLC Chromatography; Cleaning validation; Cross contamination; Penicillin; Cephalosporin; HPLC
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

TRIVEDI, H.K.; KSHTRI, N.; PATEL, M.C. A Rapid, Validated RP-HPLC Method for the Simultaneous Determination of Cleaning Validation and Cross-Contamination of 12 Beta-Lactam Compounds. Sci. Pharm. 2013, 81, 151-166.

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