Hplc Method Development and Validation for Simultaneous Estimation of Montelukast Sodium and Levocetirizine Dihydrochloride in Pharmaceutical Dosage Forms

A simple and precise HPLC method was developed for estimation of Montelukast sodium (MTKT) and Levocetirizine dihydrochloride (LCTZ) in pure and pharmaceutical dosage form. HPLC separation was achieved with a Phenomenex (Torrance, CA) C18 column (250 mm × 4.6 mm id, 5 μm particle size) as stationary phase and methanol: Trichloroacetic acid: Acetonitril (90:5:5, v/v/v) as eluent, at a flow rate of 1.0 ml/min. UV detection was performed at 231 nm. The retention time of Levocetirizine dihydrochloride and Montelukast sodium were found to 2.4 and 3.5 min respectively. Results of the analysis were validated by recovery studies. The stability of Montelukast sodium was maintained by carrying out all the operations in amber colored glass wares with minimal exposure to light. The result of the studies showed that the proposed RP-HPLC method is simple, rapid, accurate & precise, which can be used for the routine determination of Montelukast sodium and Levocetirizine dihydrochloride in bulk and in its pharmaceutical dosage forms.