ISSN: 2249–9504
CAS CODEN: IJPCDX

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF MONTELUKAST SODIUM IN BULK AND IN PHARMACEUTICAL FORMULATION

Abstract

Author(s): K. Naga Raju, T. Gopala Swamy, A. Lakshmana Rao

A rapid and sensitive RP-HPLC method with UV detection for routine analysis of montelukast sodium in bulk and in pharmaceutical formulation was developed. Chromatography was performed with mobile phase containing a mixture of ammonium acetate buffer and methanol in the ratio of 15:85 v/v with flow rate 1.0 ml/min. In the range of 50-150 µg/ml, the linearity of montelukast sodium shows a correlation coefficient of 0.999. The proposed method was validated by determining sensitivity accuracy, precision, robustness, stability, specificity, selectivity and system suitability parameters.

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