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