Method development and validation for the simultaneous determination of fexofenadine hydrochloride and montelukast sodium using rp-hplc

Abstract

–This research paper describes simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method for the simultaneous determination of fexofenadine hydrochloride and Montelukast sodium in combined dosage form. The separation was carried out on agilent T.C – C18 column(2)4.6×250m.m with 5 μm internal diameter using acetonitrile: TEA (P H 6) (80:20v/v) as mobile phase at the flow rate of 1ml/min. RP-HPLC separation of the two drugs was carried out in the absorbance mode at 220 nm. The drugs were resolved satisfactorily with Rt values of 3.21 ± 0.01 and 6.66 ± 0.01 for FEX and MTKT, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with r 2 =0.9996 and 0.9998 for FEX and MTKT, respectively in the concentration range of 12144 μg/ml for FEX and 1-12μg/ml for MTKT. The method was validated for precision, robustness, specificity and accuracy. The limit of detection and quantitation were 1.41 and 4.29 μg/ml, respectively for FEX and 0.02 and 0.06 μg/ml, respectively for MTKT. The proposed developed RP-HPLC method can be applied for identification and quantitative determination of FEX and MTKT in bulk drug and drug formulation. Keywords––fexofenadine hydrochloride; montelukast sodium; RP-HPLC; validation.