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Abstract
A stable, linear, simple, rapid, accurate and selective RP-HPLC method has been developed for the quantitation of theophylline and montelukast in the pharmaceutical formulation using methanol (100 %) as mobile phase and at the flow rate of 1 ml/minute. An ODS C-18 Kromacil (250 mm×4.60 mm) column used as stationary phase. The retention time of the theophylline and montelukast were 4.173 and 2.910 minute respectively. Linear regression analysis data show a good linear relationship between response and concentration in the range of 2-10 µg/ml; detection carried out at 210 nm; with the correlation cofficient of 0.9980 and 0.9960 for theophylline and montelukast respectively and the linear regression equation for theophylline was Y=11067X+5506; (R2=0.9980) and for montelukast, Y= 39614X+ 6086 (R2=0.9960). The parameter studied were retention time, linearity, accuracy, precision, detection limit, quantitation limit and stability. Percent recoveries obtained for theophylline and montelukast were 99.27 and 96.88 respectively. LOD values were 0.0073 µg/ml and 0.0434 µg/ml for theophylline and montelukast respectively. LOQ values were 0.0219 µg/ml and 0.1302 µg/ml for theophylline and montelukast respectively. The statistical analysis proved that the proposed method is precise, accurate, selective and rapid for the simultaneous estimation of theophylline and montelukast.