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Abstract

METHOD DEVELOPMENT AND VALIDATION OF GENOTOXIC IMPURITIES METHYL METHANESULFONATE AND METHYL IODIDE IN MONTELUKAST SODIUM DRUG SUBSTANCE BY GC-MS

Dr.Nalavade Atul Kakasaheb*, K. Ramakrishna, V. Srinivasarao

ABSTRACT

Montelukast sodium is a leukotriene receptor antagonist (LTRA) and is used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. Manufacturing process of montelukast(Fig. 1) sodium involves use of methyl iodide (fig. 2) and methanesulfonyl chloride. Also methanol was used as solvent in the process and it is a well known fact that methanesulfonyl chloride does react with alcohols to form corresponding mesylate i.e. it would form methylmethanesulfonate (fig. 3). As per the IARC monograph methyl methanesulfonateisgenotoxic impurity and being aliphatic halide, methyl iodide is also a genotoxic alerting impurity. Hencethe study wasproposed and completed for the content of methyl iodide and methyl methanesulfonate in montelukast sodium using gas chromatographic technique with mass spectrometer as detector. Based on the daily dose evaluation limit wasdecided as 150μg/g. Validation of the method was proposed and completedbased on International conference on harmonization guidelines.The results obtained after completion of validation were all within the set acceptance criteria. The LOD and LOQ values established for Methyl iodide were2μg/g and6μg/g (i.e. 0.02μg/ml and 0.06μg/ml) respectively. Similarly LOD and LOQ values established for Methyl methanesulfonatewere2μg/g and 6μg/g (i.e. 0.02μg/ml and 0.06μg/ml) respectively. Percentage recovery results and Linearity for both the components were very well within the limits and hence the range of the method was from LOQ to 150% with respect to the evaluation limit. Also three commercial batches of montelukast sodium were analyzed in the validated method. In all the three batches the content of Methyl Iodide was observed below LOQ while, the content of Methyl methanesulfonatewas not detected.

Keywords: Montelukast Sodium, Gas chromatography, Massspectrometer, Methyl Iodide, Methyl methanesulfonate, Genotoxic Impurity.


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