Abstract
A short selective, precise, accurate and sensitive stability-indicating gradient LC-MS/MSn method was developed for the quantitative determination of process-related impurities and degradation products of Montelukast in pharmaceutical oral dosage formulations. During the stress study, the degradation products of Montelukast were well-resolved from Montelukast and its impurities and the mass balances were found to be satisfactory in all the stress conditions, thus proving the stability-indicating capability of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, ruggedness, and robustness. During the stability analysis of the drug product, one unknown impurity was detected by the above stability-indicating method. The flow rate was 0.5 ml/min and effluent was monitored at 226nm. Retention time was found to be 7.836±0.012 min. The LOD and LOQ values were found to be 0.2099 (μg/ml) and 0.6362 (μg/ml) respectively.
Highlights
Montelukast is a leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies
The present study describes the separation of different impurities of Montelukast, as well as the development and validation of a stability-indicating RP-UPLC method for the estimation of degradation and process-related impurities of Montelukast
3.1 Validation The analytical method was validated with respect to parameters such as linearity, precision, specificity and accuracy, limit of detection (LOD), limit of quantitation (LOQ) and robustness in compliance with ICH guidelines
Summary
Montelukast is a leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. Montelukast blocks the action of leukotriene D4 on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene, and results in less inflammation. The present study describes the separation of different impurities of Montelukast, as well as the development and validation of a stability-indicating RP-UPLC method for the estimation of degradation and process-related impurities of Montelukast. Forced degradation studies were performed on the drug product to show the stability-indicating nature of the method. These studies were performed in accordance with established ICH guidelines
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