Development and Validation of a Reversed Phase Hplc Method for Simultaneous Determination of Levocetirizine and Montelukast Sodium in Tablet Dosage Form

A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of levocetirizine and montelukast sodium in tablets. The chromatographic separation was carried out on Atlantis C-18 analytical column (4.6×150 mm; 5μm) with a mixture of 10Mm acetonitrile:ammonium acetate (65:35 % v/v and pH 4.2 was adjusted with orthophosphoric acid) as a mobile phase; at a flow rate of 1.0 mL/min. UV detection was performed at 230 nm. The retention times were 3.03 and 6.28 min for levocetirizine and montelukast sodium respectively. Calibration plots were linear (r2=0.999) over the concentration range of 25-75 μg/mL for levocetirizine and 50-150 μg/mL for montelukast sodium. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of levocetirizine and montelukast sodium in bulk and tablet dosage form.