Research Journal of Pharmacy and Technology

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Development and Validation of an Analytical Liquid Chromatography-Tandem Mass Spectroscopy Method for the Estimation Febuxostat in Pharmaceutical Formulation


Affiliations
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
2 Indian Pharmacopoeia Commission, New Delhi, India
     

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A rapid LC-MS/MS method has been developed and validated for the quantitative determination of Febuxostat from the commercially available formulations. The separation was achieved using Zorbax SB C18 column (4.6 × 50 mm, 5 μm) as a stationary phase and the mobile phase consists of (10 mM) Ammonium formate (pH4.0): methanol (10:90 v/v) with a flow of 0.6 mL/min. Detection was carried out by triple quadrupole mass spectrometry with electrospray ionization in positive mode with proton adducts at m/z 316.95→260.95 to monitor Febuxostat within a run time of 2 min. The linearity of the method was found over a concentration range of 4 to 55 ng/mL with a regression analysis of 0.997. The percentage recovery of the present method was found to be 97.16 to 99.46%. The LC-MS/MS method was validated as per ICH guidelines. The developed method can be successfully applied for the estimation of Febuxostat in the commercial formulation and in bulk drug.

Keywords

Febuxostat, Formulation, LC-MS/MS, Validation, Electrospray Ionization.
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  • Development and Validation of an Analytical Liquid Chromatography-Tandem Mass Spectroscopy Method for the Estimation Febuxostat in Pharmaceutical Formulation

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Authors

Lingamallu Venkata Sai Krishna
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
S. T. Narenderan
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
Ramshankar Nayak
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
S. N. Meyyanathan
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
B. Babu
Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, India
M. Kalaivani
Indian Pharmacopoeia Commission, New Delhi, India

Abstract


A rapid LC-MS/MS method has been developed and validated for the quantitative determination of Febuxostat from the commercially available formulations. The separation was achieved using Zorbax SB C18 column (4.6 × 50 mm, 5 μm) as a stationary phase and the mobile phase consists of (10 mM) Ammonium formate (pH4.0): methanol (10:90 v/v) with a flow of 0.6 mL/min. Detection was carried out by triple quadrupole mass spectrometry with electrospray ionization in positive mode with proton adducts at m/z 316.95→260.95 to monitor Febuxostat within a run time of 2 min. The linearity of the method was found over a concentration range of 4 to 55 ng/mL with a regression analysis of 0.997. The percentage recovery of the present method was found to be 97.16 to 99.46%. The LC-MS/MS method was validated as per ICH guidelines. The developed method can be successfully applied for the estimation of Febuxostat in the commercial formulation and in bulk drug.

Keywords


Febuxostat, Formulation, LC-MS/MS, Validation, Electrospray Ionization.

References