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Nayak, Ramshankar
- 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
1,
S. T. Narenderan
1,
Ramshankar Nayak
1,
S. N. Meyyanathan
1,
B. Babu
1,
M. Kalaivani
2
Affiliations
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, IN
2 Indian Pharmacopoeia Commission, New Delhi, IN
1 Department of Pharmaceutical Analysis, JSS College of Pharmacy (JSS Academy of Higher Education and Research, Mysuru) Udhagamandalam, IN
2 Indian Pharmacopoeia Commission, New Delhi, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 5 (2019), Pagination: 2137-2140Abstract
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
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