Investigating the stress effects on Fexofenadine hydrochloride and Montelukast sodium in bulk and tablet dosage form using a validated LC-DAD method
ABSTRACT
The main aim was to develop RP-HPLC method for the simultaneous estimation of Fexofenadine hydrochloride and Montelukast sodium in tablet dosage form. A mobile phase comprising solvent A as 0.1% v/v trifluoroacetic acid in water and solvent B as acetonitrile with methanol in the ratio of 2:3% v/v was used and the flow was set in a gradient mode with a stationary phase of phenyl-hexyl silica column (150 × 4.6 mm, 5µ i.d).The detection wavelength is 254 nm using PDA detector. The method was validated according to ICH parameters. The results denote that the method is linear and within the range of 60-180 µg/ml for Fexofenadine and 5-15 µg/ ml for Montelukast with the r2 of 0.9998 and 0.9999 respectively. The degradants peaks non-interfered with main peaks. The developed method is acceptable for the determination of Fexofenadine and Montelukast in routine analysis of dosage form.
Keywords: FEX-Fexofenadine hydrochloride, MON- Montelukast sodium, Coelution, forced degradation, Gradient elution.
ACTA PHARMACEUTICA SCIENCIA Dergisi 59/2. Sayısı İçin Tıklayınız.