Stability‐indicating liquid chromatography method development and validation for impurity profiling of montelukast sodium in bulk drug and tablet dosage form
Mohan Pasham, Sharath Babu Haridasyam, N. V. V. D. Praveen Boppy, Muvvala Venkatanarayana, Ashok Kumar Palakurthi
Abstract
Abstract Montelukast sodium (MLS) is a leukotriene receptor antagonist drug used in the treatment of asthma, bronchospasm, allergic rhinitis and urticaria. A reversed‐phase high performance liquid chromatography method was developed to separate, identify and quantitative determination of MLS and its eight known organic impurities in tablet dosage form using a C 18 column and mobile phases consisting of a gradient mixture of pH 2.5 phosphate buffer and acetonitrile. The stability‐indicating character of the developed method was proven using stress testing (1 m HCl at 80°C/30 min, 1 m NaOH at 80°C/30 min, H 2 O at 80°C/30 min, 3% H 2 O 2 at 25°C/1 min, dry heat at 105°C/10 h and UV–vis light/4 days) and was validated for specificity, quantitation limit, linearity, precision, accuracy and robustness. For MLS and its eight known impurities, the quantitation limits, linearity and recoveries were 0.015–0.03 μg/ml, correlation coefficient > 0.997 ( R 2 > 0.995) and 85.5–107.0%, respectively. The developed chromatographic method is suitable for impurity profiling and also for assay determination of MLS in bulk drugs and pharmaceutical formulations. The mass values ( m/z ) of newly formed degradation products (DP1 and DP2) of montelukast sodium were identified using liquid chromatography–mass spectrometry.