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THE PHARMA REVIEW (OCTOBER 2008)

Development And Validation of Spectrophotometric Method for Determination of Montelukast Sodium in Bulk and Tablet Formulation

Varun Pawar, Lalitha N, Puranik SB, Sanjay Pai P.N, Rao G.K.

Abstract: Montelukast sodium, a specific cysteinyl leukotriene receptor antagonist, belongs to a styrylquinolines series and used in the treatment of asthma. A simple, rapid, precise and accurate spectrophotometric method has been developed for estimation of montelukast sodium in bulk and tablet formulation. In the proposed method water was used as solvent and wavelength maxima was selected at 283 nm. The proposed method was validated as per ICH method validation guidelines. Linearity was observed in the concentration range of 1 - 80 µgmL-1 (r2= 0.9990). The assay results were found to be in good agreement with label claim. The recovery studies were carried out at three different levels i.e. at 80%, 100%, 120%. The method was validated statistically for LOD, LOQ, repeatability by precision study and accuracy by recovery studies.
 
Introduction
Montelukast sodium, a specific cysteinyl leukotriene receptor antagonist, belongs to a styrylquinolines series with the chemical name 2-[1-[1(R)-[3-[2(E)-(7-chloroquinolin-2-yl)vinyl] phenyl]-3[2-(1-hydroxy-1-methylethyl)phenyl]propylsulfanylmethyl] cyclopropyl] acetic acid sodium salt used in the treatment of asthma (Fig. 1). Literature survey reveals that spectroflurometric, voltametric, and chromatotographic methods for estimation of montelukast in bulk and pharmaceutical formulations and biological fluids are available. The present study describes a simple rapid and economical UV-visible spectrophotometric estimation of montelukast in bulk and tablets. The method was validated as per ICH method validation guidelines.

 

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