Stability indicating LC method to determination of sodium montelukast in pharmaceutical dosage form and its photodegradation kinetics.

摘要

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.