title: Stability indicating LC method to determination of sodium montelukast in pharmaceutical dosage form and its photodegradation kinetics.
abstract: Reversed-phase high performance liquid chromatography (LC) method is developed for the assay of sodium montelukast in coated tables and its photodegradation kinetics. An isocratic LC separation is performed on a Zorbax XDB C18 column using a mobile phase of acetonitrile-methanol-water (pH 3.8) (75:10:15, v/v/v) at a flow rate of 0.8 mL/min and detection at 280 nm. The detector response for sodium montelukast is linear over the concentration range from 5-35 μg/mL (r = 0.9999). The specificity of the method is proved using stress conditions. The solutions are exposed to UV radiation (352 nm), alkaline and acid hydrolysis, oxidation, and temperature (80 °C). The intra- and inter-day precision show suitable results (RSD < 0.49%). The accuracy of analytical method is 100.04% (RSD = 0.44%). Detection and quantification limits are 0.10 and 0.32 μg/mL respectively. The robustness of the method is assured after small changes in chromatographic conditions. The kinetic of photodegradation using a LC method is established and it can be described by zero-order kinetics. This developed method show to be viable for the determination of sodium montelukast in pharmaceutical dosage form and satisfactory in the determination of the kinetics of degradation.
authors.affiliation: Post-Graduate Program of Pharmaceutical Sciences, Federal University of Rio Grande do Sul, Av. Ipiranga, 2752. Lab. 402, Porto Alegre-RS CEP, 90610-000, Brazil. juli_roman@yahoo.com.br
authors.forename: Juliana
authors.initials: J
authors.lastname: Roman
authors.forename: Ana R
authors.initials: AR
authors.lastname: Breier
authors.forename: Martin
authors.initials: M
authors.lastname: Steppe
mesh_terms: D000085:Acetates / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003521:Cyclopropanes; D004304:Dosage Forms; D004355:Drug Stability; D007700:Kinetics; D010782:Photolysis; D011804:Quinolines / Q000737:chemistry*; D012680:Sensitivity and Specificity; D013440:Sulfides
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D004304:Dosage Forms; D011804:Quinolines; D013440:Sulfides; C093875:montelukast