RP-HPLC Method Development and Validation for Simultaneous Estimation of Ambroxol and Levocetirizine in Solid Dosage Form

In this study reverse phase high performance liquid chromatographic method have been developed and validated for the simultaneous determination of Ambroxol and Levocetirizine in combined pharmaceutical formulation. HPLC separation was achieved with a Phenomenex-Luna, C₁₈ (250x4.6 mm, 5μ) as stationary phase and Sodium Dihydrogen phosphate buffer (pH adjusted to 3 with Ortho phosphoric acid): Methanol (30:70,v/v) as mobile phase , at a flow rate of 1ml/min, UV detection was performed at 230nm. The retention time of Ambroxol and Levocetirizine was found to be 4.2 and 5.6 min respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation and stability studies. The results of the studies showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which can be used for the routine determination of Ambroxol and Levocetirizine in Bulk and in its Pharmaceutical dosage form.