Determination of cetirizine and its impurities in bulk and tablet formulation using a validated capillary zone electrophoretic method

• Published in: Journal of analytical chemistry (New York, N.Y.) N.Y.), 2014-05, Vol.69 (5), p.442-447
• Main Authors: Sattary Javid, F., Shafaat, A., Zarghi, A.
• Format: Article
• Language: English
• Subjects: Analytical Chemistry; Cetirizine; Chemistry; Chemistry and Materials Science; Electrophoresis; Measurement
• ISSN: 1061-9348; 1608-3199
• DOI: 10.1134/S1061934814050037

A stability indicating capillary electrophoretic method for separation and determination of cetirizine dihydrochloride and its major impurities in bulk and a tablet dosage form was developed. The electrophoretic separation was performed in an uncoated fused-silica capillary (75 cm × 50 μm i.d.) using 75 mM sodium phosphate (pH 2.8) as background electrolyte, with an applied voltage of +25 kV at 25°C and UV detection at 230 nm. Fexofenadine was used as internal standard. The proposed method was found selective for determination of the main drug and its major impurities. The regression data obtained from the calibration plots indicated linear relationship ( r 2 = 0.998) over the concentration range of 40–240 μg/mL of cetirizine. Repeatability and reproducibility of the method, assessed as intra-day and inter-day variation and expressed as RSD (%), were 1.3 and 2.6, respectively. Stress tests on cetirizine under acidic, basic, oxidative and heat incubating at 80°C conditions revealed that no major compound was formed under the applied conditions and the proposed CE method is applicable for stability studies on cetirizine. Then, the method was successfully applied to the determination of cetirizine in bulk and a tablet dosage form.