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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 5
First page : ( 2137) Last page : ( 2140)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00354.8

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

Krishna Lingamallu Venkata Sai1, Narenderan S.T.1, Nayak Ramshankar1, Meyyanathan S.N.1,*, Babu B.1, Kalaivani M.2

1Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Udhagamandalam, India

2Indian Pharmacopoeia Commission, New Delhi

*Corresponding Author E-mail: snmeyyanathan@jssuni.edu.in

Online published on 8 August, 2019.

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.

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Keywords

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

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