Gradient High Performance Liquid Chromatography Method Development and Validation for Simultaneous Determination of Phenylephrine and Ibuprofen in Tablet Dosage Form

Purpose: To develop a gradient high performance liquid chromatography (HPLC) method for the simultaneous determination of phenylephrine (PHE) and ibuprofen (IBU) in solid dosage form.
Methods: HPLC determination was carried out on an Agilent XDB C-18 column (4.6 x 150mm, 5 μ particle size) with a gradient mobile phase composed of 0.1 % orthophosphoric acid and acetonitrile at a ratio of: 0.01/95/5, 2.5/95/5, 6/10/90, 8/10/90, 8.1/95/5 and 13/95/5 for time (min)/0.1 % orthophosphoric acid (%)/acetonitrile (%) at a flow rate of 1.0 mL/min. Column temperature was maintained at 30 °C and detection was carried out using a photodiode array (PDA) detector at 210 nm. Validation parameters, including system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), stability of sample and standard stock solutions as well as robustness were obtained as per International Conference on Harmonization (ICH) guidelines. The proposed method was applied to the determination of phenylephrine and ibuprofen in commercial tablets.
Results: Retention time for phenylephrine and ibuprofen were 2.7 and 8.4 min, respectively while % recovery was 99.42 and 99.80 %, respectively. The relative standard deviation (% RSD) for assay of the tablets was < 2 %.
Conclusion: The method is fast, accurate, precise and sensitive, and hence it can be employed for routine quality control of tablets containing both drugs in quality control (QC) laboratories and pharmaceutical industry.

Keywords
Phenylephrine; Ibuprofen; Simultaneous determination; Validation; Gradient HPLC