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.
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