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Simultaneous UPLC Estimation of Fexofenadine HCl and Montelukast Sodium Tablets


Affiliations
1 Department of pharmaceutical Analysis, C.L. Baid Metha College of Pharmacy, Thorapakkam, Chennai-600097, India
     

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A new simple, rapid and sensitive Gradient Ultra Performance Liquid Chromatography (UPLC) method has been developed for the determination of Fexofenadine HCl and Montelukast Sodium. The method employs Thermo Scientific UPLC system on Waters (symmetry) (c18 1.8 micron 4.6 x 50mm) column. Best chromatographic separation was achieved by using acetonitrile: 20 mM potassium dihydrogen phosphate 80:30 (v/v) adjusted to pH 5.5 using orthophosphoric acid as mobile phase at a flow rate of 1 ml/min and detection at 230 nm. Separation was completed within 10 min. The retention time of Fexofenadine HCl and Montelukast Sodium was found to be 1.022 and 3.281. The proposed method was found to have linearity in concentration range of 80-120 μg/ml and 96-144 μg/m. The developed method has been statistically validated and was found to be simple, precise, reproducible and accurate. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form.

Keywords

Fexofenadine HCl, Montelukast Sodium, UPLC Estimation, Analytical Method Validation.
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  • Simultaneous UPLC Estimation of Fexofenadine HCl and Montelukast Sodium Tablets

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Authors

Mohamed Mustafa
Department of pharmaceutical Analysis, C.L. Baid Metha College of Pharmacy, Thorapakkam, Chennai-600097, India
S. Amuthalakshmi
Department of pharmaceutical Analysis, C.L. Baid Metha College of Pharmacy, Thorapakkam, Chennai-600097, India
C. N. Nalini
Department of pharmaceutical Analysis, C.L. Baid Metha College of Pharmacy, Thorapakkam, Chennai-600097, India

Abstract


A new simple, rapid and sensitive Gradient Ultra Performance Liquid Chromatography (UPLC) method has been developed for the determination of Fexofenadine HCl and Montelukast Sodium. The method employs Thermo Scientific UPLC system on Waters (symmetry) (c18 1.8 micron 4.6 x 50mm) column. Best chromatographic separation was achieved by using acetonitrile: 20 mM potassium dihydrogen phosphate 80:30 (v/v) adjusted to pH 5.5 using orthophosphoric acid as mobile phase at a flow rate of 1 ml/min and detection at 230 nm. Separation was completed within 10 min. The retention time of Fexofenadine HCl and Montelukast Sodium was found to be 1.022 and 3.281. The proposed method was found to have linearity in concentration range of 80-120 μg/ml and 96-144 μg/m. The developed method has been statistically validated and was found to be simple, precise, reproducible and accurate. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form.

Keywords


Fexofenadine HCl, Montelukast Sodium, UPLC Estimation, Analytical Method Validation.