ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF MONTELUKAST BY UV-SPECTROSCOPY IN API& IN PHARMACEUTICAL DOSAGE FORMS

Author(s): Meenu Chaudhary*, Praveen Kumar, Divya Thapliyal

Abstract: An accurate, precise, and specific method developed for estimation of Montelukast in bulk. The API is used for the method development by UV spectroscopy with alcohol. The calibration curve method showed wavelength maxima for Montelukast at 345 nm with alcohol. This method obeys Beer’s law in the concentration range of 5-30μg/ml with correlation coefficient 0.999 for Montelukast. The precision results are not more than 2%. The percentage assay of Montelukast in API and in pharmaceutical dosage form was 100.50% and 99.08% respectively. The results of analysis have been validated in order to verify linearity, precision, and accuracy for the goal intended and further implementation for the quantification analysis in the pharmaceutical dosage form. The newly developed spectroscopic method is used for the routine analysis for Montelukast in pharmaceutical dosage forms.

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