SIMULTANEOUS ESTIMATION OF FEXOFENADINE HYDROCHLORIDE AND MONTELUKAST SODIUM IN BULK DRUG AND MARKETED FORMULATION BY RP-HPLC METHOD
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 4
Abstract
A new simple and precise accurate RP-HPLC method has been developed and validated for simultaneous estimation of Montelukast Sodium and Fexofenadine in tablet formulations. The chromatographic separation was performed in Water symmetry C8 (150X4.6mm 5µm) and mobile phase 0.05 m potassium di hydrogen ortho phosphate: acetonitrile in the ratio of 35:65 and the pH – 6 adjusted by triethylamine.The flow rate was 1.0ml/min and the wavelength selected for the quantization was 226 nm. The retention time was found to be 2.127 min for Fexofenadine and 5.650 min for Montelukast sodium .The linearity were found to be in the range of 4.8 - 28.8 µg/ml and 0.4 – 2.4 µg/ml for Fexofenadine and Montelukast respectively with the correlation co efficient of 0.999.The mean recoveries for Fexofenadine and Montelukast were 99.85 % and 100.19 % respectively, and relative standard deviation was less than 2%. Precision were performed as per ICH guidelines with the result shows relative standard deviation not more than 2%.The assay value for Fexofenadine and Montelukast were found to be 100.55 % and 100.40 % respectively.
Authors and Affiliations
M Ravisankar , Subasini Uthirapathy, Ananda Thangadurai, Jambulingam Munusamy , Dhanapal Kamalakannan
Keywords
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- EP ID EP92658
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