Development and Validation of RP-HPLC Method for the Simultaneous Determination of Levocetirizine Dihydrochloride and Ambroxol Hydrochloride in Bulk Drug and Pharmaceutical Dosage Form

Levocetirizine dihydrochloride (LCD) and Ambroxol Hydrochloride (ABH) are two chemicals used for the treatment of upper respiratory tract diseases and elevation of allergy symptoms.  Few HPLC methods were reported for the estimation of LCD and ABH in bulk and in tablet dosage form without extraction.  The present work describes a simple, precise and accurate isocratic reversed-phase HPLC method that was developed and validated for the estimation of Levocetirizine dihydrochloride and Ambroxol hydrochloride in bulk and in tablet dosage form. The proposed RP-HPLC method was carried out using Intersil C8 column (5 mm, 25 cm, 4.6 mm i.d.). The mobile phase of water: acetonitrile mixture (50:50 v/v) was adjusted to pH 3.3 using ortho-phosphoric acid and applied at a flow rate of 1mL/min and 20 mL injection volume. The detection was achieved with UV at 225 nm. The retention time of ABH and LCD was 1.80 ± 0.01 min and 3.21 ± 0.07 min, respectively. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The calibration plot was linear over the concentration range of 5-400 μg/ml for ABH and 1-35 μg/ml for LCD. The mean absolute recoveries for ABH and LCD were about 98.97 % and 100.8 %, respectively. From the validation study, it was found that the method was specific, rapid, accurate, sensitive, and reproducible.  The high recovery and low relative standard deviation confirm the suitability of the method for routine pharmaceutical quality control of both these drugs separately and in their combined dosage form.