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1 2013

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Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

Sharaf El Din M. K., Ibrahim F., Eid M. I., Wahba M. E. K.

Acta Chromatographica

2013

Vol. 25, no. 1

59--77

An accurate, simple, sensitive, and selective micellar liquid chromatographic method has been developed for the simultaneous determination of cetirizine dihydrochloride in two of its combined pharmaceutical preparations with psudoephedrine hydrochloride and/or paracetamol. The chemometrics approach was applied for the optimization of separation of the studied drugs to optimize their separation; the effect of six experimental parameters on retention was investigated by means of multivariate analysis. Separation was conducted using an ODS C18 (150 × 4.6 mm id) stainless steel column at ambient temperature with UV-detection at 250 nm. A mobile phase composed of 0.135 M sodium dodecyl sulphate, 11% 1-propanol, 0.3% tri-ethylamine in 0.02 M phosphoric acid, and adjusted to pH 3.3 has been used at a flow rate of 1 mL/min. Regression models were characterized by both descriptive and predictive ability (R2 ≥ 98.8% and R2cv ≥ 94.5%) and allowed the chromatographic separation of the drugs with a good resolution and a total analysis time within 6 min.The calibration curves were rectilinear over the concentration ranges of 0.05–1.0, 0.07–4.0, and 1.0–10.0 μg/mL for cetirizine dihydrochloride, psudoephedrine hydrochloride, and paracetamol respectively; with detection limits of 0.01, 0.05, and 0.08 μg/mL, and quantification limits of 0.04, 0.09, and 1.02 μg/mL, respectively. The results obtained were in good agreement with those obtained by the comparison method. Furthermore, the method was applied for the determination of the drugs in spiked human plasma and used to reveal the pharmacokinetic characters in a healthy volunteer treated with oral administration of the studied two combined dosage forms of cetirizine.