Simultaneous Determination of Ibuprofen and Diphenhydramine Citrate in Tablets by Validated LC

Abstract

A stability-indicating LC method was developed for the simultaneous determination of ibuprofen and diphenhydramine citrate in pharmaceutical dosage forms. The chromatographic separation was achieved on an Inertsil ODS 3V, 150 × 4.6 mm, 5 μm, column. The mobile phase contained a mixture of 50 mM potassium dihydrogen phosphate buffer:acetonitrile:triethylamine:glacial acetic acid (55:45:0.2:0.2, v/v/v/v). This method allowed the determination of 2.85–9.14 mg mL⁻¹ of ibuprofen and 0.54–1.73 mg mL⁻¹ of diphenhydramine citrate, in a diluent consisting of pH 7.2, 50 mM potassium dihydrogen phosphate buffer:acetonitrile (40:60, v/v). The flow rate was 1.2 mL min⁻¹ and the detection wavelength was 260 nm. The limit of detection for ibuprofen and diphenhydramine citrate was 1.72 and 0.54 μg mL⁻¹ and the limit of quantification was 5.73 and 1.64 μg mL⁻¹, respectively. This method was validated for accuracy, precision and linearity. The method was also found to be stability indicating.