A Hplc Method for the Estimation of Montelukast Sodium in Tablet Dosage form

K. Vanitha Prakash, J. Venkateswara Rao* and N. Appala Raju

Department of Pharmaceutical Chemistry, Sultan-Ul-Uloom College of Pharmacy, Banjara Hills, Hyderabad - 500 034 (India)

A HPLC method is described for the determination of Montelukast Sodium in tablet dosage form. Chromatography was carried on an Inertsil SIL 100 A column using a mixture of acetonitrile, ethanol and water (75:20:5 v/v) as the mobile phase at a flow rate of 1.0 ml/min with detection at 220 nm. The retention time of the drug was 3.85 min. The detector response was linear in the concentration of 2-12 mcg/ml. The limit of detection and limit of quantification was 0.1 and 0.3 mcg/ml respectively. The percentage assay of Montelukast Sodium was 99.7 %. The method was validated by determining its sensitivity, accuracy and precision. The proposed method is simple, fast, accurate and precise and hence can be applied for routine quality control of Montelukast Sodium in bulk and tablet dosage form.

Montelukast Sodium; HPLC; Estimation; Tablets