A Validated Stability Indicating Uplc Method For Montelukast Impurities In Montelukast Sodium Oral Granules

Abstract

Montelukast sodium is a selective and orally active leukotriene receptor antagonist. The main objective of this research is to develop a RP-UPLC method for the determination of impurities in Montelukast sodium Oral Granules.Chromatographic separation was achieved by using 100 x 2.1 mm, 1.7µm Acquity C18 column, 0.03 M phosphate buffer and 1% of Sodium perchlorate, pH adjusted to 4.9 was used as buffer, mobile phase containing a gradient mixture of solvent-A: (Buffer and Acetonitrile in 70:30 v/v ratio) and Sol-B: (Buffer and Acetonitrile in 30:70 v/v ratio). Gradient program was 0-4min, sol-B: 40-50; 4-11min- sol-B: 50-50; 11-22min- sol-B: 50-70; 22-25min- sol-B: 70-80; 25-28min- sol-B: 80-90, 28-38min- sol-B: 90-40 and 38-45min- sol-B: 40-40. Column temperature was maintained at 30°C, 4μL injection volume and run time was 45min. Analytes absorbance was measured at 225 nm.The developed method was validated as per ICH guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability. Validation results were found to be satisfactory and the method applicable for bulk and formulation analysis.