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The objective of this study was to develop the degradation studies of different brands of montelukast sodium in the market and its active form. Forced degradation is a process that involves degradation of drug products and drug substances at conditions more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule. Montelukast Sodium (1-[[[(1R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl) ethenyl] phenyl]-3-[2-(1-hydroxy-1- methylethyl) phenyl] -propyl] thio] methyl] cyclopropaneacetic acid, monosodium salt is a white colored powder and it is freely soluble in ethanol, methanol, and water. It is a leukotriene receptor antagonist and, used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies This drug was subjected to different stress conditions as per International Conference on Harmonization guidelines (ICH). An ultraviolet UV spectroscopic method was developed for analysis of the drug in the presence of the degradation products. Methanol was used as a solvent. The amount of degraded drugs was calculated by taking the absorbance at 285 nm. According to the assay limit of USP specified that the content should not be less than 95% and not more than 105% of labelled amount. All brands and its active form were degraded on basic pH and on acidic pH. In addition to heat exposure all brands and active form were also degraded. It was concluded that all brands and active form of montelukast degraded from ranges for all the stresses applied for degradation studies.

Keywords

Degradation Studies, Cyclopropaneacetic Acid, Montelukast Sodium, Leukotriene Receptor, Assay.

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