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Abstract
Montelukast sodium, a cysteinyl leukotriene type-1 receptor (CysLT1) antagonist, is widely used in the form of oral tablets and granules as a second-line therapy for the management of chronic asthma. Already developed HPLC method are having certain drawbacks like long run time and use of excess amount of solvents as mobile phase. To combat these problems, a new reverse phase HPLC method is developed and validated by us. The method validation performed as per ICH Q2(R1) guidelines by using parameters like Linearity, Precision, Accuracy, LOD, LOQ, Robustness, Ruggedness, Specificity, System suitability etc. In this method, the run time is less and the retention time of montelukast sodium is at 4.56 minutes.