Montelukast is a selective leukotriene receptor antagonist. It is indicated for the prophylaxis and chronic treatment of asthma including the prevention of exercise-induced bronchoconstriction. In the fiscal year 2018, Bureau of Drug and Narcotic collaborated with Food and Drug Administration Thailand randomly collected samples from manufacturers, importers and hospitals under Quality Assurance of Medicine Program. A total of 24 samples with strength of 10 mg from one importer (1 registration number) and 3 local manufacturers (3 registration numbers) were evaluated according to the United States Pharmacopeia (USP40) for identification, assay, content uniformity and organic impurities. The analytical methods were verified prior to analysis. The survey showed that all samples complied with the USP40 specifications. It can be concluded that Montelukast sodium tablets have satisfactory pharmaceutical characteristics.
Keywords: Montelukast sodium tablets, quality