Analytical Method Development And Validation Of Combination Of Anti-Asthmatic Drugs Montelukast And Doxofylline

Abstract

For qualitative and quantitative analysis there are different analytical techniques are available i.e. UV Spectrophotometry, HPLC and HPTLC chromatographic techniques. As per literature survey there are some UV, HPLC, UPLC and HPTLC analytical methods are available for Montelukast and Doxofylline individually and in a combination with other drugs but yet there is no stability indicating HPLC method reported for Montelukast and Doxofylline combinations. In current study analytical method develop and validate HPLC method is developed and validated for simultaneous quantitative estimations of Montelukast and Doxofylline. These present techniques are more efficient and sensitive as compared to other analytical techniques. The chromatographic separation achieved on Oyster C8 150 x4.6 mm 5 micron utilizing a mobile phase Water: Acetonitrile (150:850, v/v) and flow rate was 1 ml/min which shows good resolution and symmetric peak with retention time 4.507±0.04min and 9.561±0.1min for Montelukast and Doxofylline respectively. The detection wavelength selected was 250 nm. Linearity was observed in the range of 1-10 μg/ml for Montelukast and 4-24 μg/ml for Doxofylline. The degradation peaks developed under various stress condition for both Montelukast and Doxofylline were well separated from the peak of the intact drugs. The peaks of the Montelukast and Doxofylline were not remarkably shifted in the presence of the degradation peaks, which specify the stability-indicating character of the developed method.