Abstract
A simple ultraviolet spectrophotometric method for the estimation of montelukast in methanol has been devised and been compared with the existing pharmacopoeial RP-HPLC method for estimation of the drug. The limit of detection of montelukast at 283 nm was 75.2 ng/mL. The calibration was linear in the range of 3–45 μg/mL. Analytical parameters such as stability, selectivity, accuracy and precision have been established for the method in MONAKA® tablets and in human serum and evaluated statistically to assess the application of the method. The method was validated under the ICH and USP guidelines and found to comprise the advantages for simplicity, stability, sensitivity, reproducibility and accuracy for using as an alternate to the existing non-spectrophotometric methods for the routine analysis of the drug in pharmaceutical formulations and in pharmaceutical investigations involving montelukast.
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Saeed Arayne, M., Sultana, N. & Hussain, F. Spectrophotometric method for quantitative determination of montelukast in bulk, pharmaceutical formulations and human serum. J Anal Chem 64, 690–695 (2009). https://doi.org/10.1134/S1061934809070065
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DOI: https://doi.org/10.1134/S1061934809070065