Simultaneous Determination of Ibuprofen and Pseudoephedrine Hydrochloride in Pharmaceutical Tablets by Reversed-Phase HPLC

Abstract

An isocratic HPLC method was developed and validated for the simultaneous determination of ibuprofen (IBU) and pseudoephedrine hydrochloride (PSE). Chromatography was carried out on an Apex phenyl column using 0.025 M acetic acid, triethylamine solution (pH 4.5) – acetonitrile (80:20, v/v) as mobile phase at a flow rate of 1 mL · min⁻¹. UV detection was performed at a wavelength of 210 nm. The method was validated for specificity, linearity, accuracy, precision, and was successfully applied to pharmaceutical tablets of Rhinadvil®.

Keywords:

• HPLC
• ibuprofen
• pharmaceutical tablets
• pseudoephedrine hydrochloride
• validation

The authors gratefully acknowledge A. Allioui, C. Simon, and S. Mouyen for their precious collaboration on this work.

Notes

^a Replicated three times.

^b Replicated six times.

^c x and σ_X corresponds to the recovery mean and its standard deviation; n is the number of variables (n = 15); t_{(0.05;n − 1)} is the appropriate t table value at a 95% confidence level. (t_{(0.05;n − 1)} = 2.145).