Development and Validation of an HPLC Method for Simultaneous Determination of Ibuprofen and 17 Related Compounds

Development and Validation of an HPLC Method for Simultaneous Determination of Ibuprofen and 17... A reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for determination of ibuprofen and 17 related compounds (chemical process impurities and degradation products) simultaneously. This method may be used for quality control of ibuprofen-containing substances. A number of chromatographic parameters (column, flow rate, temperature, wavelength, gradient elution, buffer solution, and pH) were evaluated. An Agilent ZORBAX Eclipse Plus C18 (250 × 4.6 mm, 5 μm particle size) column at 40 °C was selected on the basis of its separation efficiency and robustness. The column was eluted at 1.0 mL min−1 with a gradient using 10 mM sodium phosphate buffer at pH 6.9 as mobile phase A and acetonitrile as mobile phase B. The ultraviolet detector was set at 214 nm. This method was validated to confirm its system suitability, specificity, linearity, precision, accuracy, sensitivity, robustness, and sample stability according to international conference on harmonization (ICH) guidelines. This method was applied to analyze seven batches of ibuprofen drug products from different manufacturers. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Chromatographia Springer Journals

Development and Validation of an HPLC Method for Simultaneous Determination of Ibuprofen and 17 Related Compounds

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Publisher
Springer Berlin Heidelberg
Copyright
Copyright © 2017 by Springer-Verlag GmbH Germany
Subject
Chemistry; Chromatography; Proteomics; Pharmacy; Laboratory Medicine; Analytical Chemistry
ISSN
0009-5893
eISSN
1612-1112
D.O.I.
10.1007/s10337-017-3358-3
Publisher site
See Article on Publisher Site

Abstract

A reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for determination of ibuprofen and 17 related compounds (chemical process impurities and degradation products) simultaneously. This method may be used for quality control of ibuprofen-containing substances. A number of chromatographic parameters (column, flow rate, temperature, wavelength, gradient elution, buffer solution, and pH) were evaluated. An Agilent ZORBAX Eclipse Plus C18 (250 × 4.6 mm, 5 μm particle size) column at 40 °C was selected on the basis of its separation efficiency and robustness. The column was eluted at 1.0 mL min−1 with a gradient using 10 mM sodium phosphate buffer at pH 6.9 as mobile phase A and acetonitrile as mobile phase B. The ultraviolet detector was set at 214 nm. This method was validated to confirm its system suitability, specificity, linearity, precision, accuracy, sensitivity, robustness, and sample stability according to international conference on harmonization (ICH) guidelines. This method was applied to analyze seven batches of ibuprofen drug products from different manufacturers.

Journal

ChromatographiaSpringer Journals

Published: Jul 25, 2017

References

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