Simultaneous Determination of Ceitrizine Hydrochloride and Ambroxol Hydrochloride in Combined Dosage form by Using RP-HPLC Method

A simple, accurate, economical and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of Cetirizine hydrochloride and Ambroxol hydrochloride in bulk and pharmaceutical formulations. The separation was achieved on a phenomenex C18 column (150 × 4.6 mm i.d, particle size of 5µ) using a mixture of methanol, acetonitrile and water in the ratio of (30:30:40v/v )as mobile phase in an isocratic elution mode, at a flow rate of 1  ml/min. The detection was monitored at 230 nm. The retention time of Cetirizine hydrochloride and Ambroxol hydrochloride was found to be around 2.27 ± 0.12 min and 4.70 ± 0.14 min respectively. Excellent linearity range was found between 1-10 µg/ml for cetirizine hydrochloride and 10-100 µg/ml for Ambroxol hydrochloride. The method was validated with respect to linearity, robustness, precision and accuracy and was successfully applied for the simultaneous determination of Cetirizine hydrochloride and Ambroxol hydrochloride from the combined dosage formulation. Key words: Cetirizine hydrochloride; Ambroxol hydrochloride; RP-HPLC method.