Stability indicating assay method for Montelukast sodium in pharmaceutical formulations by RP-HPLC

Abstract

Montelukast Sodium is used to treat asthma. A simple, precise cost effective and stability indicating RP-HPLC method has been developed and validated for the determination of Montelukast Sodium in pharmaceutical formulations. Separation of Montelukast Sodium from its potentional degradents were achieved with in shorter run time with required resolution, accuracy and precision thus enabling the utility of the method for routine analysis. Chromatographic separation was achieved on a Zorbax SB Phenyl column(50 times; 4.6 mm, 1.8;) using a mobile phase-A consisting of 0.15% trifluro acetic acid in milli-Q grade water and mobile phase-B Consist of 0.15% trifluro acetic acid in acetonitrile at a flow rate of 1.2ml per minute. The detection was made at 238nm. The retention time of Montelukast Sodium was 8.9 minutes. The method was found linear over the range of 5-15 per ml. The proposed method was validated as per the ICH and USP guidelines.