DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF FEXOFENADINE AND MONTELUKAST IN TABLETS DOSAGE FORM Authors: Nawaz MS , AHMED A, KHAN GJ AND HAMMAD AM
ABSTRACT
This research article describes simple, specific, accurate and precise Reverse Phase High
Pressure Liquid Chromatographic method for the simultaneous determination of fexofenadine
hydrochloride and Montelukast sodium in tablet dosage form. The chromatographic
separation was achieved on 4.6 mm X 10 cm column containing packing L1 as stationary
phase with a mobile phase comprising of water: methanol (35: 65) at a flow rate of
1.2mL/min, column temperature of 450C and UV detection at 254 nm. The retention time of
Fexofenadine and Montelukast Sodium hydrochloride were 6.776 min and 3.776min
respectively. The linearity were found to be in the range of 200-600 mg/mL and 200-600
mg/mL for Fexofenadine and Montelukast Sodium hydrochloride with correlation coefficient
greater than 0.999. The proposed methods were validated as per ICH guidelines for the
determination of drugs in tablet dosage form.
Keywords: Fexofenadine, Montelukast, RP-HPLC, Method Development Publication date: 01/06/2023 https://ijbpas.com/pdf/2023/June/MS_IJBPAS_2023_7213.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2023/12.6.7213