Add time:09/06/2019         Source:sciencedirect.com

A stability-indicating high-performance liquid chromatography (HPLC) of hydrophilic interactions was developed and validated for the determination of cetirizine dihydrochloride in bulk substance and in pharmaceutical dosage form. The separation was achieved on a Poroshell 120 Hilic (4.6 × 150 mm, 2.7 μm) column using a mobile phase composed of acetonitrile–0.1% formic acid (20:80 v/v) at a flow rate of 1.0 mL/min. The injection volume was 5.0 μL and the wavelength of detection was controlled at 235 nm. The method was validated by evaluating linearity, accuracy, precision, selectivity and robustness. Cetirizine dihydrochloride was the susceptible to the action of an oxidation factor. The product of its degradation under those conditions was identified with an EIS-Q-MS mass spectrometer. The hydrophilic interactions between the main analyte, its oxidation product, and the mobile and stationary phases were discussed with the support of a theoretical investigation.

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