Method development and validation for the simultaneous determination of cetirizine dihydrochloride, paracetamol, and phenylpropanolamine hydrochloride in tablets by capillary zone electrophoresis

A simple, selective, and cost effective capillary zone electrophoresis (CZE) method has been developed for the simultaneous separation and determination of cetirizine dihydrochloride (CTZ), paracetamol (PARA), and phenylpropanolamine hydrochloride (PPA) in tablets. A 10mM sodium tetraborate background electrolyte (BGE) solution (pH 9.0) was found to be suitable for separation of all the analytes. An uncoated fused-silica capillary of a total length of 76 cm (effective length 64.5 cm) was used for separation. All the analytes were completely separated within 10 min at the applied voltage of 20 kV (current produced similar to 21 mu A), and detection was performed at 195 nm with an UV detector. Ibuprofen was used as internal standard (I.S.) for the quantification of the drugs. Validation of the method was performed in terms of linearity, accuracy, precision, limit of detection (LOD), and quantification (LOQ). The linearity of the calibration curves for CTZ, PARA, and PPA (tested range) were 2-50 mu g ml(-1) (r(2) = 0.9982), 10-1000 mu g ml(-1) (r(2) = 0.9978), and 10-100 mu g ml(-1) (r(2) = 0.9986), respectively. The proposed method has been applied for the determination of active ingredients in tablets, and the recovery was found to be >= 98.60% with the relative standard deviation (R.S.D.) <= 1.56%. The LOQ of the CTZ, PARA, and PPA was found to be 2.0, 2.0, and 4.0 mu g ml(-1), respectively. There were no interfering peaks due to the excipients present in the pharmaceutical tablets. Thus, the proposed method is simple and suitable for the simultaneous analysis of active ingredients in tablet dosage forms. (c) 2006 Elsevier B.V. All rights reserved.