Analytical method development and validation for the simultaneous estimation of Montelukast and Doxofylline in bulk and pharmaceutical dosage forms by using RP-HPLC
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2014, Vol 2, Issue 2
Abstract
The present investigation describes about a simple, economic, selective, accurate, precise reverse phase high performance liquid chromatographic method for the simultaneous estimation of Montelukast and Doxofylline in pure and pharmaceutical dosage forms. Montelukast and Dxofylline were well separated using a HYPERSIL ODS, RP-18,250×4.6mm ID, 5µm Particle size and Mobile phase consisting of Ammonium acetate: Methanol (Adjusted with orthophosphoric acid to pH-4.5) in the ratio of 60:40v/v at the flow rate 1 ml/min and the detection was carried out at 219nm with PDA detector. The Retention time for Montelukast and Doxofylline were found to be 2.340 and 4.810 respectively. The developed method was validated for recovery, specificity, precision, accuracy, linearity according to ICH guidelines. The method was successfully applied to Montelukast and Doxofylline combination pharmaceutical dosage form.
Authors and Affiliations
Satya Prasad Vasarla, Duraivel, Harita Pavani, Kiran Kumar Ankalla, Sunny Babu
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