Development and Validation of RP-HPLC Method for the Estimation of Montelukast Sodium in Bulk and In Tablet Dosage Form

A simple, selective and rapid reverse phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Montelukast Sodium in bulk and in tablet dosage form has been developed and validated. Sample was resolved on a Luna Phenomenax, C18 (150mm X 4.6 mm i.d., particle size 5) column. The mobile phase consisted of Acetonitrile l : 20 mM phosphate buffer ( 80:20 v/v pH adjusted to 6.0 by using KOH ) was delivered at a flow rate of 1.0 ml/min at ambient temperature and the retention time was about 9.92 minutes. Studies were performed on an HPLC system equipped with a UV/Visible detector at 213nm. The method is specific to Montelukast sodium and able to resolve the drug peak from formulation excipients. The calibration curve was linear over the concentration range of 25-150 g/ml (R=0.9991).The results of analysis of formulation was found to be 99.80 ± 0.3268. The proposed method is applicable to routine analysis of Montelukast sodium in bulk and in tablet dosage form.