Simultaneous determination of montelukast and loratadine by HPLC and derivative spectrophotometric methods

In this study, high performance liquid chromatography (HPLC) and second derivative spectrophotometry have been used and described for the simultaneous determination of montelukast and loratadine in pharmaceutical formulations. HPLC separation was achieved with a Symmetry C18 column and sodium phosphate buffer (pH adjusted to 3.7): acetonitrile (20:80, v/v) as eluent, at a flow rate of 1.0 ml/min. UV detection was performed at 225 nm. The LC method is simple, rapid, selective and stability indicating for the determination of montelukast. 5-Methyl 2-nitrophenol was used as internal standard for the purpose of quantification of both the drugs in HPLC. In the second-order derivative spectrophotometry, for the determination of loratadine the zero-crossing technique was applied at 276.1 mn, but for montelukast peak amplitude at 359.7 nm (tangent method) was used. Both methods were fully validated and a comparison was made for assay determination of selected drugs in formulations. The results confirm that the methods are highly suitable for its intended purpose. (C) 2003 Elsevier Science B.V. All rights reserved.